FDA.reportPublic FDA data

Respitec

Primary DI
00819601026070
Brand
Respitec
Company
Airgas Therapeutics, LLC
Model
Pulmonary Function Calibration Gas
Catalog number
Z04NI61KEDC000
Device description
Description: 0.25% CO, 18% HE, 20.5% O2, BAL. N2; Cylinder: ED; Valve: CGA 973; For use with Respitec's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.;
Published
2026-07-08
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

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
00819601026070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819601026070008196010260708196010260700819601026070

GMDN Terms#

Term, Definition table
TermDefinition
Calibration gas/non-refillable cylinderA gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, cylindrical container intended to calibrate a medical device (e.g., anaesthesia unit, blood gas analyte, patient monitor) to verify that it measures, displays and/or supplies the proper gas type, concentration and/or quantity; it may in addition be used for testing a patient’s pulmonary function. This device is reusable until the contents of the container are exhausted.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure0
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
118537769
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760333380671Ulspira TSULSPIRA TSIN0001022024-01-02
00819601026025Scott Medical ProductsCalibration GasZ02NI98MUDC0062026-04-16
00819601026032Scott Medical ProductsCalibration GasZ02NI99MUDC0322026-04-16
00819601025790Alcon Laboratories Inc.ISPAN80650003262026-02-19
00819601025820GANSHORN INDUSTRIESPULMONARY FUNCTION GASZ04NI61FEDC0022026-03-23
00819601025851MasimoCalibration GasZ03XE75KUD00002025-12-19
00819601025868MasimoCalibration GasZ02NI99K15A00022025-12-19
00819601025875MasimoCalibration GasZ03NI10K15A00002025-12-19
00819601025882MasimoCalibration GasZ04OX51K15A00002025-12-19
00819601025899MasimoCalibration GasZ03NI45K15A00002025-12-19
00819601025905MasimoCalibration GasZ02NI99KUD00012025-12-19
00819601025912MasimoCalibration GasZ02NI99K15A00012025-12-19
00819601025929MasimoCalibration GasZ02NI99K15A0002025-12-19
00819601025936MasimoCalibration GasZ02OX50KUD00002025-12-19
00819601025943MasimoCalibration GasZ02NI98K15A00002025-12-19
00819601025950MasimoCalibration GasZ02OX95K15A00002025-12-19
00819601025967MasimoCalibration GasZ02NI87K15A00002025-12-19
00819601025974MasimoCalibration GasZ02NI70K15A00002025-12-19
00819601025837EscalonISPANSMPQES180@V22025-11-21
00819601025769DIAMOND DIAGNOSTICSCalibration GasZ02NI908QDC0002025-07-25

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