Identity
- Trade Name
- HomeFill® Oxygen System FDA UDI
- Generic Name
- Oxygen refillable cylinder FDA UDI
- Model / Reference
- HF2POSTD FDA UDI
Identifiers
- Catalog Number
- HF2POSTD FDA UDI
- Primary DI / UDI-DI
- 00850018761376 FDA UDI
- 510(k) Number
- K021685 FDA UDI
- FDA Product Code
- CAW FDA UDI
- GMDN Term
- Oxygen refillable cylinder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5440 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
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: Oxygen refillable cylinder
HomeFill® Oxygen System by Ventec Life Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen refillable cylinder.
- LIFE®Cylinder — Mv Life LLC · Class I
- Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve — Dynarex Corp. · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- LIFE®Cylinder — Mv Life LLC · Class I
- Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve — Dynarex Corp. · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Resp-O2 M24 Oxygen E-Cylinder 4.6 L with CGA870 Toggle Valve — Dynarex Corp. · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
Cleared under the same submission
K021685 also covers:
- Invacare® HomeFill® Cylinder Bag — Invacare Corp.
- Invacare® HomeFill® Cylinder Bag — Invacare Corp.
- Invacare® HomeFill® Cylinder Bag — Invacare Corp.
- Invacare® HomeFill® Cylinder Bag — Invacare Corp.
- HomeFill® Oxygen System — VENTEC LIFE SYSTEMS, INC.
- HomeFill® Oxygen System — VENTEC LIFE SYSTEMS, INC.
- HomeFill® Oxygen System — VENTEC LIFE SYSTEMS, INC.
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
- Ventec Life Systems, Inc.
Sources (1)
- FDA UDI 4c758198-685b-48fb-8070-3d0e76f415bd 35 fields · synced Jun 8, 2026