Identity
- Trade Name
- Marpac Inc FDA UDI
- Generic Name
- CPAP/BPAP chin strap, single-use FDA UDI
- Device Name
- Chin Strap, CPAP, Nicu, LARGE, bag contains 10ea FDA UDI
- Model / Reference
- 951D FDA UDI
- Description
- Chin Strap, CPAP, Nicu, LARGE, bag contains 10ea FDA UDI
Identifiers
- Catalog Number
- 951D FDA UDI
- Primary DI / UDI-DI
- 10653658009511 FDA UDI
- FDA Product Code
- BTK FDA UDI
- GMDN Term
- CPAP/BPAP chin strap, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5560 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CPAP/BPAP chin strap, single-use
Marpac Inc by Marpac, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP chin strap, single-use.
- APNEA HEAD & CHIN STRAP — BIRD & CRONIN, LLC · Class I
- Marpac Inc — Marpac, Inc. · 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
- Marpac, Inc.
Sources (1)
- FDA UDI 32875ae7-2ba5-4faf-94fc-294cf6532c3c 35 fields · synced Jun 1, 2026