Identity
- Trade Name
- KENTEX FDA UDI
- Generic Name
- Oxygen refillable cylinder FDA UDI
- Device Name
- OXYGEN CYLINDER D WITH TOGGLE VALVE FDA UDI
- Model / Reference
- OXYDTV FDA UDI
- Description
- OXYGEN CYLINDER D WITH TOGGLE VALVE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810003754776 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Oxygen refillable cylinder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 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
Category: Oxygen refillable cylinder
Kentex by Kentron Health Care, Inc. — Class I — 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
- HomeFill® Oxygen System — VENTEC LIFE SYSTEMS, INC. · Class II
- 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
- HomeFill® Oxygen System — VENTEC LIFE SYSTEMS, INC. · Class II
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
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 |
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Manufacturer
- Manufacturer
- Kentron Health Care, Inc.
Sources (1)
- FDA UDI a18e159c-941b-4632-8650-24d800e7282f 33 fields · synced May 30, 2026