FDA.reportPublic FDA data

NorLab

Primary DI
00860009621909
Brand
NorLab
Company
Norco, Inc.
Model
Medical Calibration Gas
Device description
Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00860009621909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009621909008600096219098600096219090860009621909

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.

Regulatory Flags#

DUNS number
043694645
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009621916NorLabMedical Blood Gas2022-12-12
00860009621923NorLabMedical Laser Gas2022-12-12

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