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Sunset Red Style Chin Strap – Fully Adjustable-Extra Large
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Sunset Red Style Chin Strap – Fully Adjustable-Extra Large FDA UDI
- Generic Name
- Anaesthesia mask strap, reusable FDA UDI
- Device Name
- Sunset Red Style Chin Strap – Fully Adjustable-Extra Large FDA UDI
- Model / Reference
- CS007-ADJXL FDA UDI
- Description
- Sunset Red Style Chin Strap – Fully Adjustable-Extra Large FDA UDI
Identifiers
- Catalog Number
- CS007-ADJXL FDA UDI
- Primary DI / UDI-DI
- 00848530082437 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
Sunset Red Style Chin Strap – Fully Adjustable-Extra Large by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Anaesthesia mask strap, reusable.
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- Headgaer disp., soft fabric, la. — Drägerwerk AG & Co. KGaA · Class I
- Inspire — Inspiration Healthcare, Ltd. · Class I
- Adult Large Head Strap For CPAP Mask — FLEXICARE MEDICAL LIMITED · Class I
- 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 280031b0-9619-4198-b69e-b4d91072bfcc 34 fields · synced Jun 8, 2026