OxyTrace Incu

FDA UDI

Class II (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: OxyTrace Incu FDA UDI
Generic Name: Conventional infant incubator FDA UDI
Model / Reference: MX01050 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675001065 FDA UDI
510(k) Number: K003067 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Conventional infant incubator

OxyTrace Incu by Drägerwerk AG & Co. KGaA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Conventional infant incubator.

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Isolette Infant Incubator, Models C2000 and C2000e — Draeger Medical Systems, Inc. · Class II
Connecting Cable(Y) For Dispo Skin Temp Probe — Atom Medical Corp · Class II
Skin Temp Probe, 10mm O.D.(Y) — Atom Medical Corp · Class II
Pneumoclean Electrostatic Filter(5 pcs/pkg) — Atom Medical Corp · Class II
Oxygen assembly, NIST fitting, male, C2000e — Draeger Medical Systems, Inc. · Class I
Weight Monitor Unit(w/NAWI Verification) — Atom Medical Corp · Class II
Isolette 8000 Infant Incubator — 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: Drägerwerk AG & Co. KGaA

Sources (1)

FDA UDI 6b577cb9-99e1-46c5-b515-670363fa5171 34 fields · synced Jun 7, 2026