Identity
- Trade Name
- Precision Medical Inc. \ Luxfer FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- 1901-76501,PM4150 SERIES,CONCENTRATOR,OXYGEN,PORTABLE, 5 LITER Manufactured by Precision Medical Inc. for Luxfer FDA UDI
- Model / Reference
- 1901-76501 FDA UDI
- Description
- 1901-76501,PM4150 SERIES,CONCENTRATOR,OXYGEN,PORTABLE, 5 LITER Manufactured by Precision Medical Inc. for Luxfer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855887006689 FDA UDI
- 510(k) Number
- K072348 FDA UDI
- FDA Product Code
- CAW FDA UDI
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Commercial Distribution
- Not 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
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
Precision Medical Inc. \ Luxfer by Precision Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K072348 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Precision Medical, Inc.
Sources (1)
- FDA UDI 758b0eb2-347a-4e90-bf32-ce46fbfd312d 36 fields · synced May 30, 2026