Pneumoclean Electrostatic Filter(5 pcs/pkg)

FDA UDI

Class II (US FDA UDI)

by Atom Medical Corp

Identity

Trade Name: Pneumoclean Electrostatic Filter(5 pcs/pkg) FDA UDI
Generic Name: Conventional infant incubator FDA UDI
Model / Reference: 60269 FDA UDI

Identifiers

Catalog Number: 60269 FDA UDI
Primary DI / UDI-DI: 04942962602693 FDA UDI
FDA Product Code: FMZ FDA UDI
GMDN Term: Conventional infant incubator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5400 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Conventional infant incubator

Pneumoclean Electrostatic Filter(5 pcs/pkg) by Atom Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Conventional infant incubator.

I.V. resuscitator bag holder assembly — Draeger Medical Systems, Inc. · Class I
Babyleo TN500 — Drägerwerk AG & Co. KGaA · Class II
Isolette Infant Incubator, Models C2000 and C2000e — Draeger Medical Systems, Inc. · Class II
Oxygen assembly, NIST fitting, male, C2000e — Draeger Medical Systems, Inc. · Class I
Isolette 8000 Infant Incubator — Draeger Medical Systems, Inc. · Class II
OxyTrace Incu — Drägerwerk AG & Co. KGaA · Class II
Giraffe Incubator Carestation — Datex-Ohmeda Inc. · Class II
Isolette 8000 plus — Draeger Medical Systems, Inc. · Class II

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: Atom Medical Corp

Sources (1)

FDA UDI ce0134b7-7da5-4f38-b51b-825ae0f51811 34 fields · synced Jun 1, 2026