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Resp-O2 Venturi Select A Vent Elongated Pediatric Masks
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Venturi Select A Vent Elongated Pediatric Masks FDA UDI
- Generic Name
- Venturi oxygen face mask FDA UDI
- Device Name
- 7' (2.1m) Crush Resistant Tubing, Standard Connector. Components: 1- Pediatric Mask, 1- 6" Flex Tube, 1- Humidity Connector, 1- 7' Oxygen Tubing, 6- Diluters (Blue 24%, Yellow 28%, White 31%, Green 35%, Pink 40%, Orange 50%) FDA UDI
- Model / Reference
- 33071 FDA UDI
- Description
- 7' (2.1m) Crush Resistant Tubing, Standard Connector. Components: 1- Pediatric Mask, 1- 6" Flex Tube, 1- Humidity Connector, 1- 7' Oxygen Tubing, 6- Diluters (Blue 24%, Yellow 28%, White 31%, Green 35%, Pink 40%, Orange 50%) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117310810 FDA UDI
- FDA Product Code
- BYF FDA UDI
- GMDN Term
- Venturi oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5600 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Venturi oxygen face mask
Resp-O2 Venturi Select A Vent Elongated Pediatric Masks by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Venturi oxygen face mask.
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- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · 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
- Dynarex Corp.
Sources (1)
- FDA UDI 35abe774-cba1-4735-b27f-a951e4d02c8d 33 fields · synced May 31, 2026