Identity
- Trade Name
- DeVilbiss FDA UDI
- Generic Name
- Fixed-regulator oxygen refillable cylinder FDA UDI
- Device Name
- D CYL W/CF REG FDA UDI
- Model / Reference
- 535D-D-CF FDA UDI
- Description
- D CYL W/CF REG FDA UDI
Identifiers
- Catalog Number
- 535D-D-CF FDA UDI
- Primary DI / UDI-DI
- 00885304002611 FDA UDI
- 510(k) Number
- K053240 FDA UDI
- FDA Product Code
- CAW FDA UDI
- GMDN Term
- Fixed-regulator 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fixed-regulator oxygen refillable cylinder
DeVilbiss by DeVilbiss Healthcare LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-regulator oxygen refillable cylinder.
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- LIFE®SoftPac — Mv Life LLC · Class I
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- MVA1 Viproxy — CAVAGNA GROUP SPA · Class I
- ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
- MADA MEDICAL PRODUCTS, INC — MADA MEDICAL PRODUCTS, INC. · Class I
- MVA2 Viproxy 1 Touch — CAVAGNA GROUP SPA · Class I
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DeVilbiss Healthcare LLC.
Sources (1)
- FDA UDI eb8a8634-4c75-4f0f-a315-96ca11a26023 37 fields · synced Jun 8, 2026