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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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Rescuer O-Mask - B0026200U0

Rescuer O-Mask with Universal Tubing (Large Adult)
B.L.S. Systems Limited
6200-U
In Commercial Distribution

  • B0026200U0 ()
  • B0026200U7 ()
  • B0026200U9 ()

  • Large Adult
6200-U

  • Non-rebreathing oxygen face mask

QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer - B238H000036420

Intracranial Dual lumen bolt kit with introducer
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036420 ()
H0000-3642

  • Intracerebral catheter cranial-fixation kit

Zephyr Patient Positioning and Transfer System - B237ZEPAPS100

Zephyr Accessory, Patient Stirrups with rail clamps
Diacor, Inc.
ZEP-APS-10
In Commercial Distribution

  • B237ZEPAPS100 ()


  • Patient lifting system stretcher

Zephyr Patient Positioning and Transfer System - B237ZEPAPS010

Zephyr Accessory, Patient Stirrups with rail clamps
Diacor, Inc.
ZEP-APS-01
Not in Commercial Distribution

  • B237ZEPAPS010 ()


  • Patient transfer system, powered

Tamper Evident Cap - B21257302FSS1

TEC with Fagron Logo. Tray of 10
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-302 FSS
In Commercial Distribution

  • B21257302FSS10 ()
  • B21257302FSS1 ()
57-302 FSS

  • Luer-formatted protective cap

Shape II System Refurbished - B2009012

Full Shape II system with paramagnetic analyzer
Shape Medical Systems, Inc.
0012-9012
In Commercial Distribution

  • B2009012 ()


  • Pulmonary function analysis system, adult

Shape Vital Sign System - B20083012

Full Shape II system with paramagnetic analyzer
Shape Medical Systems, Inc.
0008-3012
In Commercial Distribution

  • B20083012 ()


  • Pulmonary function analysis system, adult

LIFE®CPR Mask - B188LIFE1000

LIFE®CPR Mask with one-way valve.
Mv Life LLC
LIFE-100
In Commercial Distribution

  • B188LIFE1000 ()


  • Cardiopulmonary resuscitation mask, single-use

Signature - B3315851034

Dolphin Nose Dissecting Forceps With Tissue Well
SILEX MEDICAL, LLC
5851034
In Commercial Distribution

  • B3315851034 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Rigid endoscopic tissue manipulation forceps, reusable

Actiwave - B329AWVC23

Ambulatory ECG recorder with accelerometer - single channel
CAMNTECH LIMITED
Cardio
Not in Commercial Distribution

  • B329AWVC23 ()
08-603

  • Telemetric electrocardiographic ambulatory recorder
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