Identity
- Trade Name
- Jaeger Medical FDA UDI
- Generic Name
- Calibration gas/non-refillable cylinder FDA UDI
- Device Name
- Description: 99.0% O2 (U.S.P. Grade for Device Use); Cylinder: ED; Valve: CGA 870; For use with Jaeger Medical's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; Jaeger Medical Part #: 761819 FDA UDI
- Model / Reference
- Pulmonary Function Calibration Gas FDA UDI
- Description
- Description: 99.0% O2 (U.S.P. Grade for Device Use); Cylinder: ED; Valve: CGA 870; For use with Jaeger Medical's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; Jaeger Medical Part #: 761819 FDA UDI
Identifiers
- Catalog Number
- OX MDGEDC775 FDA UDI
- Primary DI / UDI-DI
- 00819601025516 FDA UDI
- FDA Product Code
- BXK FDA UDI
- GMDN Term
- Calibration gas/non-refillable cylinder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Pressure — 2000 Pound per Square Inch FDA UDITotal Volume — 540 Liter FDA UDI
Category: Calibration gas/non-refillable cylinder
Jaeger Medical by Airgas Therapeutics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Airgas Therapeutics
Sources (1)
- FDA UDI d7b2bae5-e11d-4774-b381-206a72b64a3c 37 fields · synced Jun 8, 2026