FDA.reportPublic FDA data

Scott Medical Products

Primary DI
00819601023048
Brand
Scott Medical Products
Company
AIRGAS USA LLC
Model
Biological Atmosphere
Catalog number
Z04NI87J2000000
Device description
Description: 3% H2, 5% CO2, 5% O2, BAL. N2;Cylinder: H;Valve: CGA 500;Biological Atmosphere Mixture for culture growth.
Published
2022-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00819601023048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819601023048008196010230488196010230480819601023048

GMDN Terms#

Term, Definition table
TermDefinition
Anaerobic chamberAn airtight chamber filled with a mixture of oxygen-free gases designed to allow laboratory personnel to culture specimens, observe growth, perform subsequent testing, and incubate cultures under anaerobic conditions. It is typically in the form of a framework covered with a thick, transparent, flexible polyvinyl chloride (PVC) with glove boxes (i.e., sleeve-like ports placed in the sides of the chamber that terminate in thick gloves) which allow the operators to operate and manipulate the object placed in the chamber without compromising it atmosphere.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure2000Pound per Square Inch
Total Volume6013Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius52 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-233-4334customerservice.healthcare@airliquide.com

Regulatory Flags#

DUNS number
831996595
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819601021938Scott Medical ProductsCalibration GasZ03OX508SDC0002020-05-23
00819601021235Scott Medical ProductsCalibration GasZ04OX46MSDC0022019-12-12
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
00819601024922Scott Medical ProductsAnesthesia Calibration GasZ02OX96MUD00012023-02-13
00819601024939Scott Medical ProductsAnesthesia Calibration GasZ03OX24MUD00042023-02-13
00819601024946Scott Medical ProductsAnesthesia Calibration GasZ02AI82MUD00012023-02-13

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