NeoNatalie Complete Dark (US)

FDA UDI

Class II (US FDA UDI)

by Laerdal Medical Corp.

Identity

Trade Name: NeoNatalie Complete Dark (US) FDA UDI
Generic Name: Pulmonary resuscitator, manual, reusable FDA UDI
Device Name: The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. This kit includes NeoNatalie Resuscitator, LGH-84604001, filed as DI 07045432092035 in GUDID. FDA UDI
Model / Reference: LGH-104-10003 FDA UDI
Description: The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. This kit includes NeoNatalie Resuscitator, LGH-84604001, filed as DI 07045432092035 in GUDID. FDA UDI

Identifiers

Catalog Number: LGH-104-10003 FDA UDI
Primary DI / UDI-DI: 07045432091151 FDA UDI
510(k) Number: K132172 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, manual, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Weight — 5 Kilogram FDA UDI

Category: Pulmonary resuscitator, manual, reusable

NeoNatalie Complete Dark (US) by Laerdal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K132172 also covers:

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: Laerdal Medical Corp.

Sources (1)

FDA UDI 213cf439-c115-45ec-8825-e1d30347b48e 38 fields · synced May 30, 2026