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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System used to regulate temperature and oxygen content of sterile water for a procedure.
FOCUS SURGERY INC
102-17000-0007
In Commercial Distribution

  • 00868108000274 ()


  • Ultrasonic hyperthermia system
Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.
FOCUS SURGERY INC
202-17000-0012
In Commercial Distribution

  • 00868108000229 ()


  • Ultrasonic hyperthermia system
Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.
FOCUS SURGERY INC
102-17000-0009
In Commercial Distribution

  • 00868108000212 ()


  • Ultrasonic hyperthermia system
No Description
Estill Medical Technologies, Inc.
TA-UPC
In Commercial Distribution

  • 00861816000390 ()
  • 00861816000345 ()
  • 10861816000342 ()


  • Convection blood/fluid warmer
The TA-UB1 Thermal Angel Ultra Battery is a rechargeable 12V LifePO4 (LFP) battery designed to power the Thermal Angel TA-200.
Estill Medical Technologies, Inc.
TA-UB1
In Commercial Distribution

  • 00861816000338 ()
  • 00861816000352 ()


  • Convection blood/fluid warmer
A blood warmer and IV fluid warmer, the Thermal Angel is a battery-powered disposable, lightweight easy to use portable blood and IV fluid warming device. The Thermal Angel blood warmer works in your environmen
Estill Medical Technologies, Inc.
TA-200
In Commercial Distribution

  • 00861816000314 ()
  • 00861816000307 ()
  • 00861816000321 ()


  • Convection blood/fluid warmer
This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (01003214) and the Spartan RX Printer (01003438).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420071 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420064 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373).
Spartan Bioscience Inc
01003374, 01003372, and 01003373
In Commercial Distribution

  • 00628055420057 ()
01003374, 01003372, and 01003373

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Barcode Scanner supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003359
In Commercial Distribution

  • 00628055420040 ()
01003359

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Printer supplied with the Spartan RX CYP2C19 System
Spartan Bioscience Inc
01003438
In Commercial Distribution

  • 00628055420033 ()
01003438

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Netbook supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003214
In Commercial Distribution

  • 00628055420026 ()
01003214

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Spartan RX Analyzer
Spartan Bioscience Inc
01004777
In Commercial Distribution

  • 00628055420019 ()
01004777

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
HUMIDIFIED INSUFFLATION KIT
FISHER & PAYKEL HEALTHCARE LIMITED
ST520
In Commercial Distribution

  • 09420012433985 ()
  • 09420012433978 ()
ST520

  • Insufflation gas conditioning tubing set
HUMIDIFIER SH870 115V US
FISHER & PAYKEL HEALTHCARE LIMITED
SH870JHU
In Commercial Distribution

  • 09420012433060 ()
SH870JHU

  • Insufflation gas conditioning system control unit
Solid Bolus
CDR Systems Inc
1
In Commercial Distribution

  • 10628341930410 ()
  • 00628341930413 ()
S-Bolus

  • Patient positioning thermoplastic mould material
Solid Bolus
CDR Systems Inc
1
In Commercial Distribution

  • 00628341930406 ()
  • 10628341930403 ()
S-Bolus

  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Mask
CDR Systems Inc
1
Not in Commercial Distribution

  • 10628341930380 ()
  • 00628341930383 ()


  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Materials
CDR Systems Inc
1
Not in Commercial Distribution

  • 10628341930373 ()
  • 00628341930376 ()


  • Patient positioning thermoplastic mould material
Thermoplastic Immobilization Materials
CDR Systems Inc
1
In Commercial Distribution

  • 10628341930229 ()
  • 00628341930222 ()


  • Patient positioning thermoplastic mould material
No Description
BELMONT INSTRUMENT CORPORATION
902-00048
In Commercial Distribution

  • 10896128002579 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00043
Not in Commercial Distribution

  • 10896128002296 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00036
In Commercial Distribution

  • 10896128002289 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00004
Not in Commercial Distribution

  • 10896128002265 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
LAPAROSCOPIC VESSEL HARVESTING GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
1117
In Commercial Distribution

  • 00852588007076 ()
1117

  • Insufflation gas conditioning tubing set
LAPAROSCOPIC GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
6198M
Not in Commercial Distribution

  • 00852588007038 ()
6198M

  • Insufflation gas conditioning tubing set
LAPAROSCOPIC GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
PP1000NS
Not in Commercial Distribution

  • 00852588007021 ()
PP1000NS

  • Insufflation gas conditioning tubing set
Laparoscopic gas conditioning device
LEXION MEDICAL, LLC
6198NS
Not in Commercial Distribution

  • 00852588007014 ()
6198NS

  • Insufflation gas conditioning tubing set
Laparoscopic gas conditioning device.
LEXION MEDICAL, LLC
6198
In Commercial Distribution

  • 00852588007007 ()
6198

  • Insufflation gas conditioning tubing set
JBAIDS Instrument
BIOFIRE DEFENSE, LLC
JB01
Not in Commercial Distribution

  • 00851458005006 ()
JRPD-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
WRAP, ARTEK PRO-01, UNV COMP01
THERMOTEK, INC.
0P9BATPUNVWRC01
In Commercial Distribution

  • 00850033615050 ()
0P9BATPUNVWRC01

  • Circulating-fluid localized thermal/compression therapy system wrap
Wrap, ArTek Sport,Univ-01,Qty 1
THERMOTEK, INC.
0V9BSPRTUNVWRP01
In Commercial Distribution

  • 00850033615036 ()
0V9BSPRTUNVWRP01

  • Circulating-fluid localized thermal/compression therapy system wrap
No Description
ICU MEDICAL, INC.
100/199/085
In Commercial Distribution

  • 35019315022351 ()
  • 15019315022357 ()
  • 55019315022355 ()


  • Infant resuscitation cabinet
No Description
Merchsource, LLC
1018016
In Commercial Distribution

  • 00840397501137 ()


  • Foot bath
AC Adapter Class II 12VDC 30W-Rental
Avanos Medical, Inc.
303640-RN
In Commercial Distribution

  • 00812120004000 ()
303640-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
Connector Hose 6 ft Sport Rental
Avanos Medical, Inc.
570300-RN
In Commercial Distribution

  • 00812120003980 ()
570300-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
590923-03-RN ATX WRAP FULL LEG BOOT MD RNTL,1
Avanos Medical, Inc.
590923-03-RN
In Commercial Distribution

  • 00812120003959 ()
590923-03-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
590906-03-RN ATX WRAP HALF LEG BOOT LG RNTL,1
Avanos Medical, Inc.
590906-03-RN
In Commercial Distribution

  • 00812120003935 ()
590906-03-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
590604-03-RN ATX ASSMBLD WRAP HIP GROIN LT RNTL,1
Avanos Medical, Inc.
590604-03-RN
In Commercial Distribution

  • 00812120003904 ()
590604-03-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
590500-03-RN ATX ASSMBLD WRAP BACK RNTL ,1
Avanos Medical, Inc.
590500-03-RN
In Commercial Distribution

  • 00812120003874 ()
590500-03-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
590330-03-RN ATX ASSMBLD WRAP ANKLE LG RNTL,1
Avanos Medical, Inc.
590330-03-RN
In Commercial Distribution

  • 00812120003850 ()
590330-03-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
Heat Exchanger Back Rental
Avanos Medical, Inc.
520500-03-RN
In Commercial Distribution

  • 00812120003836 ()
520500-03-RN

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-JA12 Accessory Kit, Med4 Elite, Japan, JP
Avanos Medical, Inc.
303945-JA12
In Commercial Distribution

  • 00812120003799 ()
303945-JA12

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-FR06 Accessory Kit, Med4 Elite, CH, FR
Avanos Medical, Inc.
303945-FR06
In Commercial Distribution

  • 00812120003768 ()
303945-FR06

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-FR01 Accessory Kit, Med4 Elite, NA, FR
Avanos Medical, Inc.
303945-FR01
In Commercial Distribution

  • 00812120003744 ()
303945-FR01

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-EX01 Accessory Kit, Med4 Elite, NA, ES
Avanos Medical, Inc.
303945-EX01
In Commercial Distribution

  • 00812120003706 ()
303945-EX01

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-EN13 Accessory Kit, Med4 Elite, KR, GB
Avanos Medical, Inc.
303945-EN13
In Commercial Distribution

  • 00812120003683 ()
303945-EN13

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-EN10 Accessory Kit, Med4 Elite, DK, GB
Avanos Medical, Inc.
303945-EN10
In Commercial Distribution

  • 00812120003669 ()
303945-EN10

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-EN06 Accessory Kit, Med4 Elite, CH, GB
Avanos Medical, Inc.
303945-EN06
In Commercial Distribution

  • 00812120003638 ()
303945-EN06

  • Circulating-fluid localized thermal/compression therapy system wrap
303945-EN03 Accessory Kit, Med4 Elite, UK, GB
Avanos Medical, Inc.
303945-EN03
In Commercial Distribution

  • 00812120003614 ()
303945-EN03

  • Circulating-fluid localized thermal/compression therapy system wrap
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