Identity
- Trade Name
- NEW YORK PRESBYTERIAN HOSPITAL FDA UDI
- Generic Name
- Tracheostomy mask, oxygen FDA UDI
- Device Name
- TRACHEOTOMY MASK ADULT-22MM CONNECTOR, 1/EA,50/CS FDA UDI
- Model / Reference
- 447018 FDA UDI
- Description
- TRACHEOTOMY MASK ADULT-22MM CONNECTOR, 1/EA,50/CS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216115095 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
Yes
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tracheostomy mask, oxygen
New York Presbyterian Hospital by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy mask, oxygen.
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- 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
- 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
- Asp Global, LLC
Sources (1)
- FDA UDI 5aee2a28-f10f-4ccc-aace-daa589aebbe5 33 fields · synced May 30, 2026