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

  • 00732094269079 ()
ELI230-BDA-ADAAX

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

  • 00732094269031 ()
ELI230-BDB-ADAAX

  • 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 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
No Description
GE Healthcare Finland Oy
ECG TRUNK CABLE, 3/5-LEAD W/ESU FILTER, AHA, 3.6 M/12 FT
In Commercial Distribution

  • 00840682137935 ()
2106310-001

  • Electrical-only medical device connection cable, reusable
No Description
GE Healthcare Finland Oy
ECG TRUNK CABLE, 3/5-LEAD W/ESU FILTER, IEC, 3.6 M/12 FT
In Commercial Distribution

  • 00840682137805 ()
2106310-002

  • Electrical-only medical device connection cable, reusable
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
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
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; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 20 ECGs);
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00817655020822 ()
ELI230-ADB-ACAAX

  • Electrocardiograph, professional, multichannel
Declassified as non-medical device. "EZ-ID Tape System Vibrant, System comes with eight 3 ft. rolls of tape and a rack that holds them organized and accessible for use 1x3ft rolls of Neon Blue 1x3ft rolls of Neon Yellow 1x3ft roll of Neon Green 1x3ft roll of Neon Orange 2x3ft roll of Neon Purple 2x3ft roll of Neon Pink"
ZIRC DENTAL PRODUCTS, INC.
70Z310
Not in Commercial Distribution

  • 00840161305671 ()

  • Length: 91.4 Centimeter


  • Surgical instrument track identification tape
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
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