Identity
- Trade Name
- Pediatric Tracheostomy Mask FDA UDI
- Generic Name
- Tracheostomy mask, oxygen FDA UDI
- Device Name
- Mask, Pediatric Tracheostomy FDA UDI
- Model / Reference
- 0361 FDA UDI
- Description
- Mask, Pediatric Tracheostomy FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078008917 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
Pediatric Tracheostomy Mask by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy mask, oxygen.
- NEW YORK PRESBYTERIAN HOSPITAL — Asp Global, LLC · Class I
- Resp-O2 Tracheostomy Adult Mask — Dynarex Corp. · Class I
- Resp-O2 Tracheostomy Adult Mask — Dynarex Corp. · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Westmed, Inc.
Sources (1)
- FDA UDI daaf2ec1-d96a-4325-aa82-028961056b53 33 fields · synced May 30, 2026