Identity
- Trade Name
- Resp-O2 Tracheostomy Adult Mask FDA UDI
- Generic Name
- Tracheostomy mask, oxygen FDA UDI
- Device Name
- with Swivel Tubing Connector (5.4 mm) Adaptor FDA UDI
- Model / Reference
- 34020 FDA UDI
- Description
- with Swivel Tubing Connector (5.4 mm) Adaptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117318069 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Tracheostomy mask, oxygen FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 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: Tracheostomy mask, oxygen
Resp-O2 Tracheostomy Adult Mask by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy mask, oxygen.
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- Mask tracheostomy O2Star M/L — Drägerwerk AG & Co. KGaA · Class I
- Adult Tracheostomy Mask with 22mm Swivel Connector and Head Strap — FLEXICARE MEDICAL LIMITED · Class I
- Tracheostomy Masks — WESTMED, INC. · Class I
- Pediatric Tracheostomy Mask — WESTMED, INC. · Class I
- Procure — Twin Med, LLC · Class I
- HEADSTAR — Headstar Medical Products Co., Ltd. · 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 fe33d03d-5554-46e9-a3a9-aec890765a6e 33 fields · synced May 30, 2026