Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Tracheostomy mask, oxygen FDA UDI
- Device Name
- MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA FDA UDI
- Model / Reference
- 301-184 FDA UDI
- Description
- MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA FDA UDI
Identifiers
- Catalog Number
- 301-184 FDA UDI
- Primary DI / UDI-DI
- 00810071631283 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tracheostomy mask, oxygen
Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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- 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
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
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 4910c070-43eb-4d9f-b30d-100be6542e97 34 fields · synced May 30, 2026