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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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CONFORMat VersaTek Wireless - B970CVW20

Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Wireless software features, Pre-configured wireless router, (2) 5330E Sensors, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (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 Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 VersaTek Wireless System
In Commercial Distribution

  • B970CVW20 ()
CVW2

  • Body-surface pressure mapping system

CONFORMat VersaTek Wireless - B970CVW10

Includes 1 VersaTek Cuff, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat Map, Help File, PDF of System Manual, Pre-configured wireless router, (1) 5330E Sensor, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (1) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 1 Arm/Leg Strap, 1 Velcro Cable Tie, 1 Velcro Wrist/Ankle Band, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 1 VersaTek Wireless System
In Commercial Distribution

  • B970CVW10 ()
CVW1

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094269390

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) ; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269390 ()
ELI230-ACD-ABXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094269284

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) ; ; ;
WELCH ALLYN, INC.
901130
In Commercial Distribution

  • 00732094269284 ()
ELI230-ADB-ABXXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094029123

Welch Allyn SureTemp Plus 690 Electronic Thermometer on Mobile Stand with Interchangeable Oral Probe Well, Oral Probe with 9.0 ft/2.7 m Cord, Last Temperature Recall; 3 Alkaline AA Batteries, provides 4-6 Second Oral, 10-13 Second Pediatric Axillary, and 12-15 Second Adult Axillary Temperature Readings in Fahrenheit or Celsius
WELCH ALLYN, INC.
901053
In Commercial Distribution

  • 00732094029123 ()
01690-700

  • Ophthalmic/otologic diagnostic set

Welch Allyn, Inc. - 00732094028980

Welch Allyn SureTemp Plus 692 Wall-Mount Electronic Thermometer with Interchangeable Oral Probe Well, Oral Probe with 4.0 ft/1.2 m Cord, Last Temperature Recall, 60-Second Pulse/Respiration Timer, Backlit Display with Electronic ID, Anti-Theft Security System; 3 Alkaline AA Batteries, provides 4-6 Second Oral, 10-13 Second Pediatric Axillary
WELCH ALLYN, INC.
901053
In Commercial Distribution

  • 00732094028980 ()
01692-200

  • Ophthalmic/otologic diagnostic set

Welch Allyn, Inc. - 00732094028973

Welch Allyn SureTemp Plus 692 Wall-Mount Electronic Thermometer with Interchangeable Rectal Probe Well, Rectal Probe with 4.0 ft/1.2 m Cord, Last Temperature Recall, 60-Second Pulse/Respiration Timer, Backlit Display with Electronic ID, Anti-Theft Security System; 3 Alkaline AA Batteries, provides 10-13 Second Rectal Readings in Fahrenheit or Celsius
WELCH ALLYN, INC.
901053
In Commercial Distribution

  • 00732094028973 ()
01692-201

  • Ophthalmic/otologic diagnostic set

Welch Allyn, Inc. - 00732094028959

Welch Allyn SureTemp Plus 692 Wall-Mount Electronic Thermometer (One per Room) with Interchangeable Rectal Probe Well, Rectal Probe with 9.0 ft/2.7 m Cord, Last Temperature Recall, 60-Second Pulse/Respiration Timer, Backlit Display with Electronic ID, Anti-Theft Security System; 3 Alkaline AA Batteries, provides 10-13 Second Rectal Temperature Read
WELCH ALLYN, INC.
901053
In Commercial Distribution

  • 00732094028959 ()
01692-301

  • Ophthalmic/otologic diagnostic set

COUNTER TOP BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x24.5”T - B337FHCSWC24TL220P1

Pass through 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. Stainless steel door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V
FUTURE HEALTH CONCEPTS, INC.
FHCSWC24-TL-220-P
In Commercial Distribution

  • B337FHCSWC24TL220P1 ()
FHCSWC24-TL-220-P

  • Blanket warming cabinet, dry-heat

COUNTER TOP BLANKET / FLUID WARMER Overall Size 30”W x 20.5”D x24.5”T - B337FHCSWC2418TLG2201

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. Accuracy +/- 1 degrees F. Electrical: 220V, UL/CUL listed.
FUTURE HEALTH CONCEPTS, INC.
FHCSWC24-18-TL-G-220
In Commercial Distribution

  • B337FHCSWC2418TLG2201 ()
FHCSWC24-18-TL-G-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP BLANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 24"W x 20.5"D x 24. - B337FHCSWC1824TL2201

Overall size 24"W x 20.5"D x 24.5"T Chamber size 20"W x 17"D x 15.25"T 3.0 Cubic ft. storage. Digital control. Optional adjustable shelve. Stainless steel door. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V Keyed temperature lock. Foot levelers
FUTURE HEALTH CONCEPTS, INC.
FHCSWC1824-TL-220
In Commercial Distribution

  • B337FHCSWC1824TL2201 ()
FHCSWC1824-TL-220

  • Blanket warming cabinet, dry-heat

EEG Cables and Lead Sets - 00884838037922

EEG Trunk Cable, 4 channel, reusable, 2, 7 meter (8.8 ft) long, shielded for 9 lead EEG monitoring. Use with 98980310561, 989803180521 or 989803180531 lead sets. The 4 channel trunk cable can also be used for 2 channels. In this case lead sets M1931A, M1932A, M1934A are recommended.
Philips Medizin Systeme Böblingen GmbH
EEG CBL 4CH Trunk Cable, 2.7m
In Commercial Distribution

  • 00884838037922 ()
989803180541

  • Electrical-only medical device connection cable, reusable

E-Z ID Tape - 00840161305688

Declassified as non-medical device. "EZ-ID Tape System Classic, System comes with eight 3 ft. rolls of tape and a rack that holds them organized and accessible for use 2x3ft rolls of White 2x3ft rolls of Blue 2x3ft roll of Green 1x3ft roll of Beige 1x3ft roll of Gray"
ZIRC DENTAL PRODUCTS, INC.
70Z305
Not in Commercial Distribution

  • 00840161305688 ()

  • Length: 91.4 Centimeter


  • Surgical instrument track identification tape

ECG Electrodes - 20884838013524

MX40 Patient Cable consists of 5-wire ECG lead set with integrated SpO2 cable/finger wrap sensor for patients (. 20 kg). Grabber leads, IEC color coded (white mono color lead wires). Single Patient Use. Cable length: ECG = 85 cm (33.5 .), SpO2 = 2m (6,5 ft) 1 Sales unit = 20 patient cables.
Philips Medical Systems Hsg
CBL ECG 5 LEAD GRABBER IEC+SPO2 SPU TELE
In Commercial Distribution

  • 20884838013524 ()
  • 00884838013520 ()
989803172151

  • Electrocardiographic lead set, reusable

ECG Electrodes - 20884838013500

MX40 Patient Cable consists of 5-wire ECG lead set with integrated SpO2 cable/finger wrap sensor for patients (. 20 kg). Grabber leads, AAMI color coded (white mono color lead wires). Single Patient Use. Cable length: ECG = 85 cm (33.5 .), SpO2 = 2m (6,5 ft) 1 Sales unit = 20 patient cables.
Philips Medical Systems Hsg
CBL ECG 5lead Grabber,AAMI+SpO2,SPU,Tele
In Commercial Distribution

  • 20884838013500 ()
  • 00884838013506 ()
989803172051

  • Electrocardiographic lead set, reusable

SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 26.5”D x 36”T - B286FHCSWC36TL2201

Overall size 30”W x 26.5”D 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. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 2 degrees F. Keyed temperature lock. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC36-TL-220
In Commercial Distribution

  • B286FHCSWC36TL2201 ()
FHCSWC36-TL-220

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 20.5”D x 36”T - B286FHCSWC3618TLG2201

Overall size 30”W x 20.5”D x 36”T. Chamber I.D. 26”W x 17”D x 25”T. 6.39 Cubic ft. storage. Digital control. 2 Adjustable shelves. Full view glass door. Foot levlers. Audible and visual over-temp alarm. Accuracy +/- 2 degrees F. Keyed temperature lock. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC36-18-TL-G-220
In Commercial Distribution

  • B286FHCSWC3618TLG2201 ()
FHCSWC36-18-TL-G-220

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 20.5”D x 36”T - B286FHCSWC3618TL2201

Overall size 30”W x 20.5”D x 36”T. Chamber I.D. 26”W x 17”D x 25”T. 6.39 Cubic ft. storage. Digital control. 2 Adjustable shelves. Stainless steel door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 2 degrees F. Keyed temperature lock. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC36-18-TL-220
In Commercial Distribution

  • B286FHCSWC3618TL2201 ()
FHCSWC36-18-TL-220

  • Blanket warming cabinet, dry-heat

COUNTER TOP BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x24.5”T - B286FHCSWC24TL220P1

Pass through 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. Stainless steel door. Foot levelers. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC24-TL-220-P
In Commercial Distribution

  • B286FHCSWC24TL220P1 ()
FHCSWC24-TL-220-P

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER BLANKET / FLUID WARMER Overall Size Freestanding 24”W x 20.5”D x - B286FHCSWC2460TL2201

Overall size 24”W x 20.5”D x 64.75”T. Chamber I.D. 20”W x 17”D x 49.5”T. 9.73 Cubic ft. storage. Digital control. 3 Adjustable shelves. Stainless steel door. Audible and visual over-temp alarm. Foot levelers. Accuracy +/- 1 degrees F of set point. Electrical: 220V
M.A.C. MEDICAL INC.
FHCSWC2460-TL-220
In Commercial Distribution

  • B286FHCSWC2460TL2201 ()
FHCSWC2460-TL-220

  • Blanket warming cabinet, dry-heat
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