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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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Welch Allyn, Inc. - 00732094269031

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; No accessories; USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269031 ()
ELI230-BDB-ADAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269024

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 medi-clip ends; Adult and pediatric interpretation; No accessories; USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269024 ()
ELI230-BDF-ADAAX

  • Electrocardiograph, professional, multichannel

SINGLE CHAMBER BANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 30”W x 26.5”D x 7 - B337FHCSWC72TL2201

Overall size 30”W x 26.5"D x 74.5”T. Chamber I.D. 26”W x 23”D x 61”T. 21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers. Stainless steel door. Audible and visual over-temp alarm. Keyed temperature lock-out. Accuracy +/- 3 degrees F. Electrical: 220V UL/CUL listed.
FUTURE HEALTH CONCEPTS, INC.
FHCSWC72-TL-220
In Commercial Distribution

  • B337FHCSWC72TL2201 ()
FHCSWC72-TL-220

  • Blanket warming cabinet, dry-heat

Counter Top Blanket/Fluid Warming Cabinet Overall size 30”W x 26.5”D x24.5”T - B337FHCSWC24TLG2201

Overall size 30”W x 26.5”D x 6 x 24.5”T. Chamber I.D. 26”W x 23”D x 15.25”T. 5.27 Cubic ft. storage. Digital control. 1 Adjustable shelves. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V UL/CUL listed. Key temperature lock. Foot levelers
FUTURE HEALTH CONCEPTS, INC.
FHCSWC24-TL-G-220
In Commercial Distribution

  • B337FHCSWC24TLG2201 ()
FHCSWC24-TL-G-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP/WALL MOUNT BLANKET/FLUID WARMING CABINET - B337FHCSWC1518TLLH2201

Overall size 18”W x 15.5”D x 6 x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic ft. storage. Digital control. Stainless Steel door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V, 1.75 Amp, 50/60 Hz. .39kw/hr, 1332 btu/hr.
FUTURE HEALTH CONCEPTS, INC.
FHCSWC1518-TL-LH-220
In Commercial Distribution

  • B337FHCSWC1518TLLH2201 ()
FHCSWC1518-TL-LH-220

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER BANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 30”W x 26.5”D x 7 - B286FHCSWC72TL2201

Overall size 30”W x 26.5"D x 74.5”T. Chamber I.D. 26”W x 23”D x 61”T. 21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers. Stainless steel door. Audible and visual over-temp alarm. Keyed temperature lock-out. Accuracy +/- 3 degrees F. Electrical: 220V UL/CUL listed.
M.A.C. MEDICAL INC.
FHCSWC72-TL-220
In Commercial Distribution

  • B286FHCSWC72TL2201 ()
FHCSWC72-TL-220

  • Blanket warming cabinet, dry-heat

Counter Top Blanket/Fluid Warming Cabinet Overall size 30”W x 26.5”D x24.5”T - B286FHCSWC24TLG2201

Overall size 30”W x 26.5”D x 6 x 24.5”T. Chamber I.D. 26”W x 23”D x 15.25”T. 5.27 Cubic ft. storage. Digital control. 1 Adjustable shelves. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V UL/CUL listed. Key temperature lock. Foot levelers
M.A.C. MEDICAL INC.
FHCSWC24-TL-G-220
In Commercial Distribution

  • B286FHCSWC24TLG2201 ()
FHCSWC24-TL-G-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP BLANKET/FLUID WARMER Overall Size 24”W x 26.5”D x 24.5”T - B286FHCSWC2424TL1

Overall size 24”W x 26.5”D x 6 x 24.5”T. Chamber I.D. 20”W x 23”D x 15.25”T. 5.21 Cubic ft. storage. Digital control. Optional adjustable shelve. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr.
M.A.C. MEDICAL INC.
FHCSWC2424-TL
In Commercial Distribution

  • B286FHCSWC2424TL1 ()
FHCSWC2424-TL

  • Blanket warming cabinet, dry-heat

COUNTER TOP/WALL MOUNT BLANKET/FLUID WARMING CABINET - B286FHCSWC1518TLLH2201

Overall size 18”W x 15.5”D x 6 x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic ft. storage. Digital control. Stainless Steel door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V, 1.75 Amp, 50/60 Hz. .39kw/hr, 1332 btu/hr.
M.A.C. MEDICAL INC.
FHCSWC1518-TL-LH-220
In Commercial Distribution

  • B286FHCSWC1518TLLH2201 ()
FHCSWC1518-TL-LH-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP/WALL MOUNT BLANKET/FLUID WARMING CABINET 220 VAC - B286FHCSWC1518TLGLH2201

Overall size 18”W x 15.5”D x 6 x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic ft. storage. Digital control. Full view glass door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V, 1.75 Amp, 50/60 Hz. .39kw/hr, 1332 btu/hr.
M.A.C. MEDICAL INC.
FHCSWC1518-TL-G-LH-220
In Commercial Distribution

  • B286FHCSWC1518TLGLH2201 ()
FHCSWC1518-TL-G-LH-220

  • Blanket warming cabinet, dry-heat

DUAL CHAMBER BLANKET/FLUID WARMING CABINET Overall Size 30”W x 26.5”D x 74.5”T - B286FHCDWC36TLGMB1

Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Digital control. 4 Adjustable shelves. Full view glass doors. Audible and visual over-temp alarm. Mobile base. Accuracy +/- 2 degrees F (upper chamber). Accuracy +/- 2 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .69kw/hr, 2356 btu/hr.
M.A.C. MEDICAL INC.
FHCDWC36-TL-G-MB
In Commercial Distribution

  • B286FHCDWC36TLGMB1 ()
FHCDWC36-TL-G-MB

  • Blanket warming cabinet, dry-heat

F-Scan VersaTek Wireless Datalogger - B970FVWD20

Includes 2 VersaTek Cuffs, 1 VersaTek Wireless/Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Pre-configured wireless router, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek Wireless/ Datalogger System
In Commercial Distribution

  • B970FVWD20 ()
FVWD2

  • Body-surface pressure mapping system

F-Scan VersaTek Datalogger - B970FVD20

Includes 2 VersaTek Cuffs, 1 VersaTek Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek Datalogger System
In Commercial Distribution

  • B970FVD20 ()
FVD2

  • Body-surface pressure mapping system

K2 Scientific, LLC - G136K212GDRBB0

14 Cu. Ft. High-Performance Laboratory 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 K212GDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K212GDRBB
In Commercial Distribution

  • G136K212GDRBB0 ()
K212GDR-BB

  • Blood refrigerator

Welch Allyn, Inc. - 00732094300239

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; Australia 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

  • 00732094300239 ()
ELI230-BBB-ACAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094287622

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; 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

  • 00732094287622 ()
ELI230-BCB-ACAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269765

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; US/Canada 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

  • 00732094269765 ()
ELI230-AAA-AAXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269741

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; 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

  • 00732094269741 ()
ELI230-AAA-ACAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269703

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; 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

  • 00732094269703 ()
ELI230-AAB-ACAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269611

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; US/Canada power cord; IEC 10 wire, 12-lead lead set with medi-clip ends; 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

  • 00732094269611 ()
ELI230-AAF-ACAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269604

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; Australia 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

  • 00732094269604 ()
ELI230-ABA-AAXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269598

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; Australia 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

  • 00732094269598 ()
ELI230-ABA-ACAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269567

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; Australia 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

  • 00732094269567 ()
ELI230-ABB-ACAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269512

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; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269512 ()
ELI230-ACA-ACAAX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269499

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

  • 00732094269499 ()
ELI230-ACB-AAXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269482

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

Welch Allyn, Inc. - 00732094269475

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

Welch Allyn, Inc. - 00732094269437

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

Welch Allyn, Inc. - 00732094269406

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

Welch Allyn, Inc. - 00732094269345

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
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