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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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Olimax/Wildcat Isolation Gown - 00860009514119

Non Surgical Disposable Isolation Gown AAMI Level 2 XL
Wildcat Ppe LLC
XL
In Commercial Distribution

  • 00860009514119 ()
WPPE0059

  • Isolation gown, single-use

Olimax/Wildcat Isolation Gown - 00860009514102

Non Surgical Disposable Isolation Gown AAMI Level 2 L
Wildcat Ppe LLC
L
In Commercial Distribution

  • 00860009514102 ()
WPPE0058

  • Isolation gown, single-use

Laser Gas Mixture - 00860009502048

Gases utilized as a medium for various medical lasers.
Roberts Oxygen Company, Inc.
1
In Commercial Distribution

  • 00860009502048 ()


  • Laser-generating gas

Artificial Atmosphere Mixture - 00860009502031

Used to grow and sustain anaerobic, aerobic bacteria, or cultures in a biological incubator.
Roberts Oxygen Company, Inc.
1
In Commercial Distribution

  • 00860009502031 ()


  • Anaerobic chamber

Calibration Gas Mixture - 00860009502024

Used to calibrate various medical analyzers and other medical equipment.
Roberts Oxygen Company, Inc.
1
In Commercial Distribution

  • 00860009502024 ()


  • Multiple blood gas analyte IVD, calibrator
  • Blood gas analyser IVD, point-of-care

Clinical Blood Gas Mixture - 00860009502017

For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
Roberts Oxygen Company, Inc.
1
In Commercial Distribution

  • 00860009502017 ()


  • Blood gas analyser IVD, point-of-care
  • Multiple blood gas analyte IVD, calibrator

Lung Diffusion Mixture - 00860009502000

Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.
Roberts Oxygen Company, Inc.
1
In Commercial Distribution

  • 00860009502000 ()


  • Carbon monoxide breath analyser

VCA Lite - 00860009492912

5.3 cc Vaginal Cream Applicator 3-Pack. Three applicators are packaged in a canister.
Pce, Inc.
Q033-G00-02
In Commercial Distribution

  • 00860009492912 ()


  • Vaginal applicator, single-use

VCA Lite - 00860009492905

5.3 cc Vaginal Cream Applicator in a 7-pack canister
Pce, Inc.
Q033-G00-01
In Commercial Distribution

  • 00860009492905 ()


  • Vaginal applicator, single-use

Radiology Information Systems, Inc. - 00860009490642

For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files
Radiology Information Systems, Inc.
RSVS
In Commercial Distribution

  • 00860009490642 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system digital archive device
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