Identity
- Trade Name
- Resp-O2 Oxygen Mask Non-Rebreather, Infant FDA UDI
- Generic Name
- Non-rebreathing oxygen face mask FDA UDI
- Device Name
- 7' (2.1) Crush Resistant Tubing, 600mL Reservoir Bag, Standard Connector FDA UDI
- Model / Reference
- 33054 FDA UDI
- Description
- 7' (2.1) Crush Resistant Tubing, 600mL Reservoir Bag, Standard Connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117310759 FDA UDI
- FDA Product Code
- KGB FDA UDI
- GMDN Term
- Non-rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5570 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: Non-rebreathing oxygen face mask
A Resp-O2 Oxygen Mask Non-Rebreather, Infant is a single-use device designed for infants to deliver high oxygen concentration air through a flexible, form-shaped mask. It features two unidirectional valves that prevent room air mixing with oxygen in the reservoir bag and ensure exhaled respiratory gases are not entering the bag.
Similar devices
Also classified as Non-rebreathing oxygen face mask.
- POM EZ-Lite — Stryker Corp. · Class II
- BF — Allied Medical LLC · Class I
- Rescuer O-Mask — B.L.S. Systems Limited · Class I
- BF — Allied Medical LLC · Class I
- Procedural Oxygen Mask — Stryker Corp. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Ventlab — Ventlab Corp. · 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 7e0a86e3-1ec0-433e-a9a0-978f18433f34 33 fields · synced Jul 29, 2026