Chin Strap

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Chin Strap FDA UDI
Generic Name: CPAP/BPAP chin strap, reusable FDA UDI
Device Name: CPAP Supply USA Private Labeled Sunset Healthcare Halo Style Chinstrap FDA UDI
Model / Reference: ALIN005CS025 FDA UDI
Description: CPAP Supply USA Private Labeled Sunset Healthcare Halo Style Chinstrap FDA UDI

Identifiers

Primary DI / UDI-DI: 00812028033201 FDA UDI
FDA Product Code: BTK FDA UDI
GMDN Term: CPAP/BPAP chin 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: CPAP/BPAP chin strap, reusable

Chin Strap by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 d2b1210a-f8dd-4e2a-8b49-07a1c69b9ed9 34 fields · synced May 31, 2026