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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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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); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094257892 ()
ELI230-ABA-AAAAX

  • 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; 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); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094257885 ()
ELI230-BBA-AAAAX

  • Electrocardiograph, professional, multichannel
49 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K249SDF-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K249SDFSSBB
In Commercial Distribution

  • G136K249SDFSSBB0 ()
K249SDF-SS-BB

  • Blood refrigerator/freezer
49 Cu. Ft. High-Performance Laboratory, Solid Door, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K249SDF-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K249SDFBB
In Commercial Distribution

  • G136K249SDFBB0 ()
K249SDF-BB

  • Blood refrigerator/freezer
25 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDF-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K225SDFSSBB
In Commercial Distribution

  • G136K225SDFSSBB0 ()
K225SDF-SS-BB

  • Blood refrigerator/freezer
25 Cu. Ft. High-Performance Laboratory, Solid Door, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDF-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
K2 Scientific, LLC
K225SDFBB
In Commercial Distribution

  • G136K225SDFBB0 ()
K225SDF-BB

  • Blood refrigerator/freezer
Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; UK power cord; IEC 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; Internal thermal printer (includes starter pack of thermal paper roll, 1.97 in. x 100 ft., (50mm x 30.48m) 10 rolls); LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094317565 ()
SUR12-TCD-XXAAX

  • General-purpose multi-parameter bedside monitor
Surveyor S12 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; UK power cord; AHA 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; Internal thermal printer (includes starter pack of thermal paper roll, 1.97 in. x 100 ft., (50mm x 30.48m) 10 rolls); LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094313871 ()
SUR12-UCC-XXAAX

  • General-purpose multi-parameter bedside monitor
Surveyor S12 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; Australia power cord; AHA 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; Internal thermal printer (includes starter pack of thermal paper roll, 1.97 in. x 100 ft., (50mm x 30.48m) 10 rolls); LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094300451 ()
SUR12-UBC-XXAAX

  • General-purpose multi-parameter bedside monitor
Surveyor S12 GEN1 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; Australia power cord; AHA 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; Internal thermal printer (includes starter pack of thermal paper roll, 1.97 in. x 100 ft., (50mm x 30.48m) 10 rolls); LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094296594 ()
SUR12-NBC-XXAAX

  • General-purpose multi-parameter bedside monitor
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