Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Snap adapters (set of 10) ; USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269482 ()
ELI230-ACB-ABAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269475 ()
ELI230-ACB-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269437 ()
ELI230-ACC-AAXXX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269406 ()
ELI230-ACD-AAXXX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269345 ()
ELI230-ADA-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Snap adapters (set of 10) ; USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269291 ()
ELI230-ADB-ABAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; Brazil power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269178 ()
ELI230-AEB-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; US/Canada power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Snap adapters (set of 10) ; USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269161 ()
ELI230-BAA-ABAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; US/Canada power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269154 ()
ELI230-BAA-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; US/Canada power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269130 ()
ELI230-BAB-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; UK power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269116 ()
ELI230-BCA-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269086 ()
ELI230-BDA-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Snap adapters (set of 10) ; USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269055 ()
ELI230-BDB-ABAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269048 ()
ELI230-BDB-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; Brazil power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269017 ()
ELI230-BEA-ACAAX

  • Electrocardiograph, professional, multichannel
ELI230 12-Lead Multi-Channel Electrocardiograph -Color LCD display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter roll paper - Thermal Roll appx 50 ft.); current software; Brazil power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269000 ()
ELI230-BEB-ACAAX

  • Electrocardiograph, professional, multichannel
No Description
GE Healthcare Finland Oy
ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT
In Commercial Distribution

  • 00840682137928 ()
2106309-001

  • Electrical-only medical device connection cable, reusable
No Description
GE Healthcare Finland Oy
ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT
In Commercial Distribution

  • 00840682137829 ()
2106309-002

  • Electrical-only medical device connection cable, reusable
49 Cu. Ft. High-Performance Laboratory Solid Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K249SDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K249SDRSSBB
In Commercial Distribution

  • G136K249SDRSSBB0 ()
K249SDR-SS-BB

  • Blood refrigerator
49 Cu. Ft. High-Performance Laboratory Solid Door Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K249SDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K249SDRBB
In Commercial Distribution

  • G136K249SDRBB0 ()
K249SDR-BB

  • Blood refrigerator
49 Cu. Ft. High-Performance Laboratory Glass Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K249GDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K249GDRSSBB
In Commercial Distribution

  • G136K249GDRSSBB0 ()
K249GDR-SS-BB

  • Blood refrigerator
49 Cu. Ft. High-Performance Laboratory Glass Door Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K249GDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K249GDRBB
In Commercial Distribution

  • G136K249GDRBB0 ()
K249GDR-BB

  • Blood refrigerator
30 Cu. Ft. High-Performance Laboratory Solid Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K230SDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K230SDRSSBB
In Commercial Distribution

  • G136K230SDRSSBB0 ()
K230SDR-SS-BB

  • Blood refrigerator
30 Cu. Ft. High-Performance Laboratory Solid Door Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K230SDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K230SDRBB
In Commercial Distribution

  • G136K230SDRBB0 ()
K230SDR-BB

  • Blood refrigerator
30 Cu. Ft. High-Performance Laboratory Glass Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K230GDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K230GDRSSBB
In Commercial Distribution

  • G136K230GDRSSBB0 ()
K230GDR-SS-BB

  • Blood refrigerator
30 Cu. Ft. High-Performance Laboratory, Glass Door, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K230GDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K230GDRBB
In Commercial Distribution

  • G136K230GDRBB0 ()
K230GDR-BB

  • Blood refrigerator
25 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K225SDRSSBB
In Commercial Distribution

  • G136K225SDRSSBB0 ()
K225SDR-SS-BB

  • Blood refrigerator
25 Cu. Ft. High-Performance Laboratory Solid Door Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K225SDRBB
In Commercial Distribution

  • G136K225SDRBB0 ()
K225SDR-BB

  • Blood refrigerator
25 Cu. Ft. High-Performance Laboratory, Glass Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225GDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K225GDRSSBB
In Commercial Distribution

  • G136K225GDRSSBB0 ()
K225GDR-SS-BB

  • Blood refrigerator
25 Cu. Ft. High-Performance Laboratory Glass Door Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225GDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K225GDRBB
In Commercial Distribution

  • G136K225GDRBB0 ()
K225GDR-BB

  • Blood refrigerator
Overall size 30”W x 20.5”D x 6 x 24.5”T. Chamber I.D. 26”W x 17”D x 13.5”T. 3.45 Cubic ft. storage. Digital control. 1 Adjustable shelves. Glass door. Foot levelers. Audible and visual over-temp alarm. Data Logger Accuracy +/- 1 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .30kw/hr, 1024 btu/hr. UL/CUL listed.
M.A.C. MEDICAL INC.
SKSWC24-18-TL-G-D
In Commercial Distribution

  • B286SKSWC2418TLGD1 ()
SKSWC24-18-TL-G-D

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 20.5”D x 6 x 24.5”T. Chamber I.D. 26”W x 17”D x 13.5”T. 3.45 Cubic ft. storage. Digital control. 1 Adjustable shelves. Stainless steel door. Foot levelers. Audible and visual over-temp alarm. Data Logger Accuracy +/- 1 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .30kw/hr, 1024 btu/hr. UL/CUL listed.
M.A.C. MEDICAL INC.
SKSWC24-18-TL-D
In Commercial Distribution

  • B286SKSWC2418TLD1 ()
SKSWC24-18-TL-D

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 20.5”D x 74.5”T. Chamber I.D. 26”W x 17”D x 61”T. 15.6 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 3 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .53kw/hr, 1810 btu/hr. UL/CUL listed.
M.A.C. MEDICAL INC.
FHCSWC72-18-TL-G-R
In Commercial Distribution

  • B286FHCSWC7218TLGR1 ()
FHCSWC72-18-TL-G-R

  • Blanket warming cabinet, dry-heat
Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth 21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Stainless steel door. Audible and visual over-temp alarm. Keyed temperature lock-out. Accuracy +/- 3 degrees F. Data Logger Mobile Base Electrical: 120V, 7.5 Amp, 50/60 Hz. .53kw/hr, 1810 btu/hr. UL/CUL listed.
M.A.C. MEDICAL INC.
FHCSWC72-18-TL-D-MB
In Commercial Distribution

  • B286FHCSWC7218TLDM1 ()
FHCSWC72-18-TL-D-MB

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 20.5”D x 64.5”T. 13.05 Cubic ft. storage Chamber I.D. 26”W x 17”D x 51”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point 3 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Mobile base Electrical: 120V, 7.5 Amp, 50/60 Hz .46 kw/hr, 1570 btu/hr
M.A.C. MEDICAL INC.
FHCSWC60-TL-MB
In Commercial Distribution

  • B286FHCSWC60TLMB1 ()
FHCSWC60-TL-MB

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 20.5”D x 6 x 64.5”T. Overall size recessed. 30”W x 20.5”D x 60T. Chamber I.D. 26”W x 17”D x 51”T. 13.05 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 3 degrees F. Key temperature lock. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC60-TL-G-220
In Commercial Distribution

  • B286FHCSWC60TLG2201 ()
FHCSWC60-TL-G-220

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 20.5”D x 64.5”T. 13.05 Cubic ft. storage Chamber I.D. 26”W x 17”D x 51”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point 3 Adjustable shelves Digital control Glass door Audible and visual over-temp alarm Foot levelers Electrical: 120V, 7.5 Amp, 50/60 Hz .46 kw/hr, 1570 btu/hr
M.A.C. MEDICAL INC.
FHCSWC60-TL-G
In Commercial Distribution

  • B286FHCSWC60TLG1 ()
FHCSWC60-TL-G

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 20.5”D x 64.5”T. 13.05 Cubic ft. storage Chamber I.D. 26”W x 17”D x 51”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point 3 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Foot levelers Electrical: 120V, 7.5 Amp, 50/60 Hz .46 kw/hr, 1570 btu/hr
M.A.C. MEDICAL INC.
FHCSWC60-TL
In Commercial Distribution

  • B286FHCSWC60TL1 ()
FHCSWC60-TL

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 26.5”D x 6 x 36”T. Chamber I.D. 26”W x 23”D x 25”T. 8.63 Cubic ft. storage. Digital control. 2 Adjustable shelves. Stainless steel door. Audible and visual over-temp alarm. Accuracy +/- 2 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .35kw/hr, 1195 btu/hr. UL/CUL listed. Mobile base
M.A.C. MEDICAL INC.
FHCSWC36-TL-MB
In Commercial Distribution

  • B286FHCSWC36TLMB1 ()
FHCSWC36-TL-MB

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 26.5”D x 36”T. 8.63 Cubic ft. storage Chamber I.D. 26”W x 23”D x 25”T. Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point 2 Adjustable shelves Digital control Glass door Audible and visual over-temp alarm Mobile base Electrical: 120V, 7.5 Amp, 50/60 Hz .35 kw/hr, 1195 btu/hr
M.A.C. MEDICAL INC.
FHCSWC36-TL-G-MB
In Commercial Distribution

  • B286FHCSWC36TLGMB1 ()
FHCSWC36-TL-G-MB

  • Blanket warming cabinet, dry-heat
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