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Ventimask Fixed Concentration Mask High O2 Concentration Set with 40% & 60% Vent
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Ventimask Fixed Concentration Mask High O2 Concentration Set with 40% & 60% Vent FDA UDI
- Generic Name
- Venturi oxygen face mask FDA UDI
- Model / Reference
- 037-10-009U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788752868 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Venturi oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Venturi oxygen face mask
Ventimask Fixed Concentration Mask High O2 Concentration Set with 40% & 60% Vent by Flexicare Medical Limited — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Venturi oxygen face mask.
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- Mask ventkit O2Star fixed S — Drägerwerk AG & Co. KGaA · 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
- Flexicare Medical Limited
Sources (1)
- FDA UDI 2ff83db9-0dfd-445e-b90e-9e49d4f7fd55 32 fields · synced May 30, 2026