Ventilator Kit

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Ventilator Kit FDA UDI
Generic Name: Anaesthesia breathing circuit, single-use FDA UDI
Device Name: Pediatric Passive Circuit with Swivel Exhalation Port Comparable to OEM# 1073228, 1073236 This kit contains: (1) VEN002 and (1) TUB006SS FDA UDI
Model / Reference: VC100P FDA UDI
Description: Pediatric Passive Circuit with Swivel Exhalation Port Comparable to OEM# 1073228, 1073236 This kit contains: (1) VEN002 and (1) TUB006SS FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530105310 FDA UDI
FDA Product Code: CAH FDA UDI
GMDN Term: Anaesthesia breathing circuit, single-use 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

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: Anaesthesia breathing circuit, single-use

Ventilator 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 d9b03ec7-e645-4725-af4c-505c52fd759a 34 fields · synced Jun 6, 2026