Identity
- Trade Name
- Live Active Five EUDAMEDFDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Live Active Five Portable Oxygen Concentrator EUDAMEDPM4155, Live Active Five, Portable Oxygen Concentrator FDA UDI
- Model / Reference
- PM4155 EUDAMEDPM4155 Portable Oxygen Concentrator FDA UDI
- Description
- PM4155, Live Active Five, Portable Oxygen Concentrator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855887006887 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855887006887 EUDAMED
- 510(k) Number
- K103563 FDA UDI
- FDA Product Code
- CAW FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
EUDAMED
Measuring Function
Yes
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
Live Active Five by Precision Medical, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00855887006887 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Precision Medical Inc
- EUDAMED SRN
- US-MF-000008706
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9b8ceb2f-96d9-4acc-a70d-679c2b3638be 61 fields · synced Jul 11, 2026
- FDA UDI 9be4dc31-8cab-4452-b6cc-a48abc339331 34 fields · synced May 30, 2026