Identity
- Trade Name
- DRIVEMEDICAL FDA UDI
- Generic Name
- Oxygen refillable cylinder FDA UDI
- Device Name
- RespiratoryRespiratory Disposables Product Description: E-Cylinder Key plastic,25/bg FDA UDI
- Model / Reference
- EK-1 FDA UDI
- Description
- RespiratoryRespiratory Disposables Product Description: E-Cylinder Key plastic,25/bg FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383116464 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Oxygen refillable cylinder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5860 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oxygen refillable cylinder
Drivemedical by Drive Devilbiss Healthcare — 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
- 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
- Resp-O2 M24 Oxygen E-Cylinder 4.6 L with CGA870 Toggle Valve — Dynarex Corp. · Class I
- Resp-O2 M9 Oxygen C-Cylinder 1.7L — Dynarex Corp. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI b240e8c7-7437-47f6-b842-c9907770a00b 33 fields · synced Jun 8, 2026