Calibration Gas Mixture

GUDID 00860009502024

Used to calibrate various medical analyzers and other medical equipment.

Roberts Oxygen Company, Inc.

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Primary Device ID00860009502024
NIH Device Record Key1d4fe9c1-8081-4b17-88e9-f5e6c2b30c7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalibration Gas Mixture
Version Model Number1
Company DUNS791818008
Company NameRoberts Oxygen Company, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009502024 [Primary]

FDA Product Code

BXKGas, Calibration (Specified Concentration)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-23
Device Publish Date2022-11-15

Devices Manufactured by Roberts Oxygen Company, Inc.

00860009502017 - Clinical Blood Gas Mixture2022-11-23 For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
00860009502024 - Calibration Gas Mixture2022-11-23Used to calibrate various medical analyzers and other medical equipment.
00860009502024 - Calibration Gas Mixture2022-11-23 Used to calibrate various medical analyzers and other medical equipment.
00860009502031 - Artificial Atmosphere Mixture2022-11-23 Used to grow and sustain anaerobic, aerobic bacteria, or cultures in a biological incubator.
00860009502048 - Laser Gas Mixture2022-11-23 Gases utilized as a medium for various medical lasers.
00860009502000 - Lung Diffusion Mixture2022-11-17 Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.

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