NeoPIP Infant Resuscitator Universal Mounting Bracket

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name: NeoPIP Infant Resuscitator Universal Mounting Bracket FDA UDI
Generic Name: Pulmonary resuscitator, pneumatic, reusable FDA UDI
Model / Reference: NF-101U FDA UDI

Identifiers

Primary DI / UDI-DI: 05055931119593 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, pneumatic, 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

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

FDA UDI

Category: Pulmonary resuscitator, pneumatic, reusable

NeoPIP Infant Resuscitator Universal Mounting Bracket by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Flexicare Medical Limited

Sources (1)

FDA UDI ac8f0a30-db6e-4c89-8f96-759a31d597a2 32 fields · synced Jun 8, 2026