Mobilaire Kit

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Mobilaire Kit FDA UDI
Generic Name: Anaesthesia conduction filter FDA UDI
Device Name: This kit contains: 2 OF9001 Foam Cabinet Filters, 1 BFH65 HEPA Filter 6in Capsule, 1 BF516 Final Bacteria Filter. FDA UDI
Model / Reference: OF9001SP FDA UDI
Description: This kit contains: 2 OF9001 Foam Cabinet Filters, 1 BFH65 HEPA Filter 6in Capsule, 1 BF516 Final Bacteria Filter. FDA UDI

Identifiers

Catalog Number: OF9001SP FDA UDI
Primary DI / UDI-DI: 00848530050924 FDA UDI
FDA Product Code: JRL FDA UDI
GMDN Term: Anaesthesia conduction filter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 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

Yes

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 conduction filter

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

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Also classified as Anaesthesia conduction filter.

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Covidien NPB 492A Style Foam Cabinet Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
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Oxygen Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · 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 8c248b73-27b0-46d5-bac9-14a741f261c1 35 fields · synced May 31, 2026