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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Disposable Hyperinflation System, 2L bag, 7' O2 and pressure lines, adult mask
WESTMED, INC.
900 000 625
Not in Commercial Distribution

  • 05707480137756 ()
  • 05707480137749 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off Valve
WESTMED, INC.
900 000 624
In Commercial Distribution

  • 05707480137732 ()
  • 05707480137725 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1L Bag, 7' O2 and Manometer Infant Mask, 40 cm H2O Pop-off Valve
WESTMED, INC.
900 000 623
Not in Commercial Distribution

  • 05707480137718 ()
  • 05707480137701 ()


  • Ventilator breathing circuit, single-use
Hyperinflation System, 1L Bag (not made with latex), 7' O2 and Pressure Lines, Pediatric Mask, 40 cm H2O pop-valve
WESTMED, INC.
900 000 622
Not in Commercial Distribution

  • 05707480137695 ()
  • 05707480137688 ()


  • Ventilator breathing circuit, single-use
Hyperinflation System, 1L Bag (not made with latex), 7' O2 and Pressure Lines, Infant Mask, 40 cm H2O pop-valve
WESTMED, INC.
900 000 621
Not in Commercial Distribution

  • 05707480137671 ()
  • 05707480137664 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off Valve
WESTMED, INC.
900 000 628
In Commercial Distribution

  • 05707480137657 ()
  • 05707480137640 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 7' O2 and Manometer, 40 CM POP off Valve, Infant Mask
WESTMED, INC.
900 000 618
In Commercial Distribution

  • 05707480137619 ()
  • 05707480137602 ()


  • Ventilator breathing circuit, single-use
Hyperinflation System, 1/2L bag (not made with Latex), 7' O2 and pressure lines, Infant mask, 40 cm H2O pop-valve
WESTMED, INC.
900 000 616
Not in Commercial Distribution

  • 05707480137572 ()
  • 05707480137565 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 3L Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
900 000 601
In Commercial Distribution

  • 05707480103089 ()
  • 05707480103218 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 2L Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
900 000 602
In Commercial Distribution

  • 05707480102938 ()
  • 05707480103201 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
900 000 603
In Commercial Distribution

  • 05707480102945 ()
  • 05707480103195 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Manometer
WESTMED, INC.
900 000 604
In Commercial Distribution

  • 05707480102952 ()
  • 05707480103188 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Infant Mask
WESTMED, INC.
900 000 607
Not in Commercial Distribution

  • 05707480103171 ()
  • 05707480102983 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Manometer, Series 900 Neonatal Mask
WESTMED, INC.
900 000 605
In Commercial Distribution

  • 05707480102969 ()
  • 05707480103164 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1L Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
900 000 608
Not in Commercial Distribution

  • 05707480102990 ()
  • 05707480103157 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1L Bag (Latex Free), 7' O2 and Manometer
WESTMED, INC.
900 000 609
In Commercial Distribution

  • 05707480103003 ()
  • 05707480103140 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Infant Mask
WESTMED, INC.
900 000 610
Not in Commercial Distribution

  • 05707480103133 ()
  • 05707480103010 ()


  • Ventilator breathing circuit, single-use
Hyperinflation Elbow, Manometer Dock, 7' O2 and Manometer
WESTMED, INC.
900 000 611
In Commercial Distribution

  • 05707480103027 ()
  • 05707480103126 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Manometer, Series 900 Infant Mask
WESTMED, INC.
900 000 606
In Commercial Distribution

  • 05707480102976 ()
  • 05707480103119 ()


  • Ventilator breathing circuit, single-use
ManaCold Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad. Commonly used following knee surgery, shoulder surgery or back surgery ManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting
Manamed, Inc.
ManaCold
In Commercial Distribution

  • 00850998008980 ()
MANACOLD01

  • Circulating-fluid localized thermal therapy system
No Description
CORVENT MEDICAL, INC
Patient Circuit Kit
In Commercial Distribution

  • 00850057117332 ()
  • 00850057117172 ()
91-101-US304

  • Ventilator breathing circuit, single-use
Digital Dry Bath
AWARENESS TECHNOLOGY, INCORPORATED
2200
In Commercial Distribution

  • 00850229007089 ()


  • Laboratory shaker
Hyperinflation System, 1L bag (not made with Latex), 7' O and Pressure lines, 40cm H2O Pop-Valve
WESTMED, INC.
900 000 619
Not in Commercial Distribution

  • 05707480137633 ()
  • 05707480137626 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2 Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O pop-off valve
WESTMED, INC.
900 000 617
In Commercial Distribution

  • 05707480137596 ()
  • 05707480137589 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L bag (not made with latex), 7' O2 and pressure Lines, Neonatal mask, H2O Pop-off valave
WESTMED, INC.
600 000 615
In Commercial Distribution

  • 05707480137558 ()
  • 05707480137541 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2 Bag 7' O2 and Manometer 40 cm H2O Pop-Off Valve
WESTMED, INC.
900 000 614
In Commercial Distribution

  • 05707480137534 ()
  • 05707480137527 ()


  • Ventilator breathing circuit, single-use
Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O pop-valve
WESTMED, INC.
900 000 627
Not in Commercial Distribution

  • 05707480137510 ()
  • 05707480137503 ()


  • Ventilator breathing circuit, single-use
3.9 cu ft halo heat fluid warmer
ENTHERMICS, INC.
EC390L
Not in Commercial Distribution

  • 00851962007039 ()


  • Conduction blood/fluid warmer
3.4 cu ft halo heat fluid warmer
ENTHERMICS, INC.
EC340L
Not in Commercial Distribution

  • 00851962007022 ()


  • Conduction blood/fluid warmer
2.3 cu ft halo heat fluid warmer
ENTHERMICS, INC.
EC230L
Not in Commercial Distribution

  • 00851962007015 ()


  • Conduction blood/fluid warmer
Rechargeable battery pack for powering the °M Warmer
Mequ A/S
MWS106
In Commercial Distribution

  • 05745000140046 ()
MWS106

  • Conduction blood/fluid warmer
Rechargeable battery pack for powering the °M Warmer
Mequ A/S
MWS105
In Commercial Distribution

  • 05745000140039 ()
MWS105

  • Conduction blood/fluid warmer
The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances. The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack+ (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140046) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).
Mequ A/S
MWS006
In Commercial Distribution

  • 05745000140022 ()
MWS006

  • Conduction blood/fluid warmer
The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances. The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140039) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).
Mequ A/S
MWS005
In Commercial Distribution

  • 05745000140015 ()
MWS005

  • Conduction blood/fluid warmer
Experience the next level of pain relief with the Brace Direct BlueIce Cold Cryotherapy Machine. Perfect for arthritis, post-surgical recovery, and injury treatment, this machine combines portability and efficiency for targeted cold therapy.
BRACE ALIGN LLC
CTY243
In Commercial Distribution

  • 00689481624044 ()


  • Circulating-fluid localized thermal therapy system
Experience fast relief from muscle and joint pain with our state-of-the-art Frozen Ice Cold Therapy Machine. The ergonomic therapy pad provides comprehensive coverage, targeting areas like the knee, ankle, shoulder, and more, ensuring deep therapeutic comfort.
BRACE ALIGN LLC
CTY194-Unit-Plus-Uni-Pad
In Commercial Distribution

  • 00686162753284 ()


  • Circulating-fluid localized thermal therapy system
Experience targeted relief from joint pain, post-workout fatigue, and post-surgery inflammation with the Brace Direct Frozen Heat Therapy Unit. Portable, versatile, and designed for both cold and hot treatments to speed up recovery.
BRACE ALIGN LLC
CTY159-2
In Commercial Distribution

  • 00686162751389 ()


  • Circulating-fluid localized thermal therapy system
Neonatal Transport Humidification System
INTERNATIONAL BIOMEDICAL, LTD.
9400
In Commercial Distribution

  • 00850018561648 ()
9400

  • Heated respiratory humidifier
Charger for charging the Power Pack / Power Pack+ (rechargeable battery packs)
Mequ A/S
MWS301
In Commercial Distribution

  • 05700002076847 ()
MWS301

  • Conduction blood/fluid warmer
Disposable IV Fluid / Blood Warmer unit
Mequ A/S
MWS201
In Commercial Distribution

  • 05700002076823 ()
  • 05700002076816 ()
MWS201

  • Conduction blood/fluid warmer
No Description
NORTH EAST SCIENTIFIC INC
R-RFS2-6-12
In Commercial Distribution

R-RFS2-6-12

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
Blood warmer
Stihler Electronic GmbH
P2XNA
In Commercial Distribution

  • 04260114149910 ()
109822

  • Conduction blood/fluid warmer
Blood warmer
Stihler Electronic GmbH
PF2300NA
In Commercial Distribution

  • 04260114149897 ()
PF2300NA

  • Conduction blood/fluid warmer
Blood and infusion warmer
Stihler Electronic GmbH
AP220AU
In Commercial Distribution

  • 04260114140955 ()
AP220AU

  • Conduction blood/fluid warmer
Blood and infusion warmer
Stihler Electronic GmbH
AP260SNA
In Commercial Distribution

  • 04260114140931 ()
AP260SNA

  • Conduction blood/fluid warmer
Blood and infusion warmer
Stihler Electronic GmbH
AP260NA
In Commercial Distribution

  • 04260114140924 ()
AP260NA

  • Conduction blood/fluid warmer
Blood and infusion warmer
Stihler Electronic GmbH
AP220SNA
In Commercial Distribution

  • 04260114140917 ()
AP220SNA

  • Conduction blood/fluid warmer
Blood and infusion warmer
Stihler Electronic GmbH
AP220NA
In Commercial Distribution

  • 04260114140900 ()
AP220NA

  • Conduction blood/fluid warmer
Blood and infusion warmer
Stihler Electronic GmbH
AFP302NA
In Commercial Distribution

  • 04260114140894 ()
AFP302NA

  • Conduction blood/fluid warmer
Blood and infusion warmer
Stihler Electronic GmbH
AFP300NA
In Commercial Distribution

  • 04260114140887 ()
AFP300NA

  • Conduction blood/fluid warmer
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