Identity
- Trade Name
- MEDLINE UNITE FDA UDI
- Generic Name
- Oxygen compressor, home-use FDA UDI
- Device Name
- COMPRESSOR/DISTRACTOR FDA UDI
- Model / Reference
- MPN40013 FDA UDI
- Description
- COMPRESSOR/DISTRACTOR FDA UDI
Identifiers
- Catalog Number
- MPN40013 FDA UDI
- Primary DI / UDI-DI
- 10888277699137 FDA UDI
- FDA Product Code
- HXW FDA UDI
- GMDN Term
- Oxygen compressor, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Oxygen compressor, home-use
Medline Unite by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen compressor, home-use.
- DeVilbiss iFill — DeVilbiss Healthcare LLC. · Class II
- HomeFill® Oxygen System — VENTEC LIFE SYSTEMS, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 1d5b5ddb-ad80-4285-8710-05fa9e8e36e5 35 fields · synced Jun 1, 2026