Demistifier

FDA UDI

Class II (US FDA UDI)

by Peace Medical, Inc.

Identity

Trade Name: Demistifier FDA UDI
Generic Name: Anaesthesia workstation gas scavenger FDA UDI
Device Name: Portable HEPA Air Filtration System FDA UDI
Model / Reference: 2000A FDA UDI
Description: Portable HEPA Air Filtration System FDA UDI

Identifiers

Primary DI / UDI-DI: 00860013652302 FDA UDI
510(k) Number: K902161 FDA UDI
FDA Product Code: CBN FDA UDI
GMDN Term: Anaesthesia workstation gas scavenger FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5430 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Anaesthesia workstation gas scavenger

Demistifier by Peace Medical, 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: Peace Medical, Inc.

Sources (1)

FDA UDI db63f300-f54a-4507-92de-9df873028e54 36 fields · synced Jun 8, 2026