Resuscitation Accessory

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: RESUSCITATION ACCESSORY FDA UDI
Generic Name: Airway pressure monitor, non-powered FDA UDI
Device Name: Sunset Disposable Pressure Manometer, L-Shape - 25PCS FDA UDI
Model / Reference: RES8201LNS FDA UDI
Description: Sunset Disposable Pressure Manometer, L-Shape - 25PCS FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530105013 FDA UDI
FDA Product Code: CAE FDA UDI
GMDN Term: Airway pressure monitor, non-powered FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Airway pressure monitor, non-powered

Resuscitation Accessory 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 e3d6495c-e54e-4230-82a5-06031f386201 34 fields · synced Jun 1, 2026