FDA.report

Scott Medical Products

Primary DI
00819601020412
Brand
Scott Medical Products
Company
AIRGAS USA LLC
Model
Pulmonary Function Gas
Catalog number
Z04NI685EA0033
Device description
Description: 0.3% CO, 10% He, 21% O2, Bal. N2; Cylinder: EL; Valve: CGA 973; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
Published
2019-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BXKGas, Calibration (Specified Concentration)

Product Code Classifications

CodeDeviceSpecialtyClass
BXKGas, Calibration (Specified Concentration)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819601020412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819601020412008196010204128196010204120819601020412

GMDN Terms

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.

Device Sizes

TypeValueUnit
Pressure2000Pound per Square Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius52 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-233-4334customerservice.healthcare@airliquide.com

Regulatory Flags

DUNS number
831996595
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00819601021938Scott Medical ProductsCalibration GasZ03OX508SDC0002020-05-23
00819601025103Scott Medical ProductsAnesthesia Calibration GasZ04OX33KSD00002023-03-06
00819601024991Scott Medical ProductsAnesthesia Calibration GasZ02OX86MUD00002023-02-24
00819601025004Scott Medical ProductsAnesthesia Calibration GasZ03OX17MUD00002023-02-24
00819601025011Scott Medical ProductsAnesthesia Calibration GasZ03OX20MUD00012023-02-24
00819601025028Scott Medical ProductsAnesthesia Calibration GasZ03OX11MUD00012023-02-24
00819601025035Scott Medical ProductsAnesthesia Calibration GasZ03OX56MUD00002023-02-24
00819601025042Scott Medical ProductsCalibration GasZ02NI854SD00002023-02-24
00819601025059Scott Medical ProductsCalibration GasZ02NI804SD00002023-02-24
00819601025066Scott Medical ProductsCalibration GasZ03NI15415A00002023-02-24
00819601025073Scott Medical ProductsAnesthesia Calibration GasZ04NI70M15A00002023-02-25
00819601025080Scott Medical ProductsCalibration GasZ02NI83415A00012023-02-25
00819601025097Scott Medical ProductsCalibration GasZ02NI99415A00002023-02-25
00819601024960Bionostic, Inc.Calibration GasZ03NI85430000012023-02-17
00819601024977Bionostic, Inc.Calibration GasZ03NI82430000012023-02-17
00819601024984Bionostic, Inc.Calibration GasZ03NI874300Z2352023-02-17
00819601024632Scott Medical ProductsCalibration GasZ02NI978200C0002023-02-11
00819601024649Scott Medical ProductsAnesthesia Calibration GasZ03OX61MUD00012023-02-11
00819601024656Scott Medical ProductsAnesthesia Calibration GasZ03OX69MUD00042023-02-11
00819601024663Scott Medical ProductsAnesthesia Calibration GasZ02AI97MUD00012023-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00819601025578Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01
00819601025585Jaeger MedicalAirgas Therapeutics, LLCBXK2025-05-01