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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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Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and a travel bag.
CEREVE INC
VA Kit
In Commercial Distribution

  • 00864302000317 ()


  • Circulating-fluid localized thermal therapy system
Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps.
CEREVE INC
EOS-30000-007
In Commercial Distribution

  • 00864302000300 ()


  • Circulating-fluid localized thermal therapy system
Histogelâ„¢ Starter Kit includes: Wonderblock Aluminum Cooling Blocks, Histogelâ„¢, Histogelâ„¢ Incubator & Tube Block, Disposable Pipettes and Thermometer (Mercury Free).
RICHARD-ALLAN SCIENTIFIC COMPANY
Histogelâ„¢ Starter Kit 120V
In Commercial Distribution

  • 00673693344692 ()
HGSK-2050-1

  • Test tube heater
  • Agar powder IVD
Disposable Hyperinflation System, 3L bag, 7' O2 and Pressure Lines, Adult mask
WESTMED, INC.
900 000 626
Not in Commercial Distribution

  • 05707480137770 ()
  • 05707480137763 ()


  • Ventilator breathing circuit, single-use
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
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
MED3272
In Commercial Distribution

  • 00851962007725 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
P-2040
In Commercial Distribution

  • 00851962007718 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
MED3373
In Commercial Distribution

  • 00851962007701 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
EC1540
In Commercial Distribution

  • 00851962007695 ()


  • Multi-purpose warming cabinet, stationary
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