Identity
- Trade Name
- Ventlab FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- PEDIATRIC HIGH CONCENTRATION NON-REBREATHER FDA UDI
- Model / Reference
- 2202 FDA UDI
- Description
- PEDIATRIC HIGH CONCENTRATION NON-REBREATHER FDA UDI
Identifiers
- Catalog Number
- 2202 FDA UDI
- Primary DI / UDI-DI
- 10889483066089 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Dimensions & Sizes
- Size
- Length — 7 Feet FDA UDI
Ventlab by Ventlab Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Ventlab Corp.
Sources (1)
- FDA UDI 3917029d-0690-4a9f-bdbc-7484b8b48430 37 fields · synced May 31, 2026