Identity
- Trade Name
- Liberator EUDAMEDFDA UDI
- Generic Name
- Stationary liquid oxygen container FDA UDI
- Device Name
- Liberator EUDAMEDBase Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI FDA UDI
- Model / Reference
- 13261699 EUDAMEDFDA UDI
- Description
- Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI FDA UDI
Identifiers
- Primary DI / UDI-DI
- M766132616990 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M766132616990 EUDAMED
- 510(k) Number
- K800742 FDA UDI
- FDA Product Code
- BYJ FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Stationary liquid oxygen container FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5655 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function analysis system, adult
Liberator by Caire Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-M766132616990 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CAIRE Inc.
- EUDAMED SRN
- US-MF-000013030
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 9147c872-30a1-4f3b-b39d-3b04a35769ef 61 fields · synced May 30, 2026
- FDA UDI 0490fb95-08f7-4395-8abb-3769d859b441 34 fields · synced May 30, 2026