Identity
- Trade Name
- Universal Neoprene Chinstrap FDA UDI
- Generic Name
- Anaesthesia mask strap, reusable FDA UDI
- Device Name
- Universal Neoprene Chinstrap. Can be used with any nasal mask or nasal pillows, one size fits most. FDA UDI
- Model / Reference
- CS001 FDA UDI
- Description
- Universal Neoprene Chinstrap. Can be used with any nasal mask or nasal pillows, one size fits most. FDA UDI
Identifiers
- Catalog Number
- CS001 FDA UDI
- Primary DI / UDI-DI
- 00848530080013 FDA UDI
- FDA Product Code
- BTK FDA UDI
- GMDN Term
- Anaesthesia mask strap, reusable 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
No
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: Anaesthesia mask strap, reusable
Universal Neoprene Chinstrap by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Anaesthesia mask strap, reusable.
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- Inspire — Inspiration Healthcare, Ltd. · Class I
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- Headgear disp., soft rub., small — Drägerwerk AG & Co. KGaA · 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
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 9ef424e3-289c-46e8-9850-d064b791267f 35 fields · synced May 30, 2026