Babyleo TN500

FDA UDI

Class II (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: Babyleo TN500 FDA UDI
Generic Name: Conventional infant incubator FDA UDI
Model / Reference: 2M60000 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675436607 FDA UDI
510(k) Number: K162821 FDA UDI
K182859 FDA UDI
FDA Product Code: FMZ FDA UDI
FMT FDA UDI
GMDN Term: Conventional infant incubator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5400 FDA UDI
880.5130 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Conventional infant incubator

Babyleo TN500 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.

I.V. resuscitator bag holder assembly — Draeger Medical Systems, Inc. · Class I
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Drägerwerk AG & Co. KGaA

Sources (1)

FDA UDI b2573bc9-3d10-47ff-a23c-acca6b08c177 33 fields · synced May 30, 2026