FDA.reportPublic FDA data

MediPure Lung Diffusion Mixture

Primary DI
00850046301162
Brand
MediPure Lung Diffusion Mixture
Company
Linde Gas & Equipment Inc.
Model
1
Device description
Lung Diffusion Mixture (of Specified Concentration)GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion 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
00850046301162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046301162008500463011628500463011620850046301162

GMDN Terms#

Term, Definition table
TermDefinition
Carbon monoxide breath analyserAn electronic device intended to be used in a clinical setting to measure the concentration of carbon monoxide (CO) in a gas-mixture sample, exhaled by a patient, using a particular method (e.g., electrochemical, infrared spectroscopy, gas chromatography). It may be used to aid in determining the patient's ventilatory status (typically the lung diffusing capacity), or for determining exhaled CO levels (e.g., during jaundice screening in newborns, or in smoking cessation programs); it may also have the capacity to measure the concentration of CO in the atmosphere.

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
00850046301179MediPure Blood Gas 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