Jaeger Medical

Basic Information

• Brand Name: Jaeger Medical
• Primary DI: 00819601025639
• Version / Model: Pulmonary Function Calibration Gas
• Catalog Number: Z05NI78FEA001C
• Company Name: Airgas Therapeutics, LLC
• Labeler DUNS: 118537769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-01
• Public Version: 1
• Public Version Date: 2025-05-09
• Public Version Status: New
• Public Device Record Key: b8eee27a-f2e5-45f8-8430-ef69e0355b01

Device Description

Description: 0.3% CO, 0.3% CH4, 5% CO2, 16% O2, Bal. N2; Cylinder: EAL; Valve: CGA 973; For use with Jaeger Medical's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; Jaeger Medical Part #: V892590-13

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXK	Gas, Calibration (Specified Concentration)	Anesthesiology	868.6400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65331	Calibration gas/non-refillable cylinder	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819601025639	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Pressure	1305	Pound per Square Inch
Total Volume	420	Liter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 52 Degrees Celsius