Cough Assist Kit

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Cough Assist Kit FDA UDI
Generic Name: Respirator filter/cartridge, particulates FDA UDI
Device Name: (1) RES013, (1) BF2200, (1) TUB06 - Cough Assist Kit Respironics OEM#1090835 *PRIVATE LABELED* FDA UDI
Model / Reference: IND004CAKIT001 FDA UDI
Description: (1) RES013, (1) BF2200, (1) TUB06 - Cough Assist Kit Respironics OEM#1090835 *PRIVATE LABELED* FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530101855 FDA UDI
FDA Product Code: CAH FDA UDI
GMDN Term: Respirator filter/cartridge, particulates FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5260 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: Respirator filter/cartridge, particulates

Cough Assist Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

FDA UDI 5949e750-1cfe-4e4b-8d1d-e78d238749ce 34 fields · synced May 30, 2026