FDA.reportPublic FDA data

MediPure Blood Gas Mixture

Primary DI
00850046301179
Brand
MediPure Blood Gas Mixture
Company
Linde Gas & Equipment Inc.
Model
1
Device description
Blood Gas Mixture (of Specified Concentration)GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Blood Gas Mixture
Published
2023-08-15
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
00850046301179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046301179008500463011798500463011790850046301179

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042845636
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850046301209NOxBOXi NOXKIT 3-221LGENOXKIT3-222024-01-26
00850046301223NOxBOXi NOXKIT 3-HFJV1LGENOXKIT3-HFJV2024-01-26
00850046301025NOxBOXi NOXKIT 1-101LGENOXKIT-1-102023-05-01
00850046301063NOxBOXi NOXKIT 2-221LGENOXKIT-2-222023-05-01
00850046301087NOxBOXi NOXKIT 2-151LGENOXKIT-2-152023-05-01
00850046301100NOxBOXi NOXKIT HFJV1LGENOXKIT-HFJV2023-05-01
00850046301124NOxBOXi NOXKIT EMER1LGENOXKIT-EMER2023-05-01
00850046301148NOxBOXi NOxFLOW1NXBNOXFLOW-22023-08-30
00850046301155NOxBOXi NOxFLOW1LGENOXFLOW-22023-08-30
00850046301162MediPure Lung Diffusion Mixture12023-08-15
00850046301186MediPure Laser Gas Mixture12023-08-15
00850046301193MediPure Calibration Gas Mixtures12023-08-15
00850046301049NOxBOXi NOXKIT 2-121LGENOXKIT-2-122023-05-01
00850046301032NOxBOXi NOXKIT 1-101LGENOXKIT-1-102023-05-01
00850046301056NOxBOXi NOXKIT 2-121LGENOXKIT-2-122023-05-01
00850046301070NOxBOXi NOXKIT 2-221LGENOXKIT-2-222023-05-01
00850046301094NOxBOXi NOXKIT 2-151LGENOXKIT-2-152023-05-01
00850046301117NOxBOXi NOXKIT HFJV1LGENOXKIT-HFJV2023-05-01
00850046301131NOxBOXi NOXKIT EMER1LGENOXKIT-EMER2023-05-01
00850046301001NOxBOXi System-I Test Kit12023-02-13

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