Semi-Iris Access Port Cover(20 pcs/pkg)

FDA UDI

Class II (US FDA UDI)

by Atom Medical Corp

Identity

Trade Name: Semi-Iris Access Port Cover(20 pcs/pkg) FDA UDI
Generic Name: Transport infant incubator FDA UDI
Model / Reference: 60861 FDA UDI

Identifiers

Catalog Number: 60861 FDA UDI
Primary DI / UDI-DI: 04942962608619 FDA UDI
FDA Product Code: FPL FDA UDI
GMDN Term: Transport infant incubator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5410 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

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: Transport infant incubator

Semi-Iris Access Port Cover(20 pcs/pkg) by Atom Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transport infant incubator.

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Breathing bag set with PEEP valve, disposable — Draeger Medical Systems, Inc. · Class II
185A+ Infant Incubator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
CosyCrib — INSPIRATION HEALTHCARE GROUP PLC · Class I
Aviator Transport Incubator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
A750i Infant Incubator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
CosyCrib — INSPIRATION HEALTHCARE GROUP PLC · 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 II	Pending data

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Manufacturer

Manufacturer: Atom Medical Corp

Sources (1)

FDA UDI f491f899-74fa-4d9f-ae1c-0e831969ca80 34 fields · synced Jun 8, 2026