FDA.reportPublic FDA data

Clinical Blood Gas Mixture

Primary DI
00860009502017
Brand
Clinical Blood Gas Mixture
Company
Roberts Oxygen Company, Inc.
Model
1
Device description
For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BXKGas, Calibration (Specified Concentration)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXKGas, Calibration (Specified Concentration)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009502017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009502017008600095020178600095020170860009502017

GMDN Terms#

Term, Definition table
TermDefinition
Blood gas analyser IVD, point-of-careA mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the calculation of other blood gas parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient] in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791818008
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009502024Calibration Gas Mixture12022-11-15
00860009502031Artificial Atmosphere Mixture12022-11-15
00860009502048Laser Gas Mixture12022-11-15
00860009502000Lung Diffusion Mixture12022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819601026025Scott Medical ProductsAirgas Therapeutics, LLCBXK2026-04-16
00819601026032Scott Medical ProductsAirgas Therapeutics, LLCBXK2026-04-16
00819601025820GANSHORN INDUSTRIESAirgas Therapeutics, LLCBXK2026-03-23
00819601025851MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025868MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025875MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025882MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025899MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025905MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025912MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025929MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025936MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025943MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025950MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025967MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025974MasimoAirgas Therapeutics, LLCBXK2025-12-19
00819601025769DIAMOND DIAGNOSTICSAirgas Therapeutics, LLCBXK2025-07-25
00819601025776DIAMOND DIAGNOSTICSAirgas Therapeutics, LLCBXK2025-07-25
00819601025783DIAMOND DIAGNOSTICSAirgas Therapeutics, LLCBXK2025-07-25
00819601025721SIEMENS HEALTHCAREAirgas Therapeutics, LLCBXK2025-06-20
00819601025738SIEMENS HEALTHCAREAirgas Therapeutics, LLCBXK2025-06-20
00819601025653Scott Medical ProductsAirgas Therapeutics, LLCBXK2025-05-22
00819601025493Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01
00819601025509Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01
00819601025516Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01
00819601025523Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01
00819601025530Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01
00819601025547Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01
00819601025554Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01
00819601025561Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01