Puffin Lite Infant Resuscitator

FDA UDI

Class II (US FDA UDI)

by International Biomedical, Ltd.

Identity

Trade Name: Puffin Lite Infant Resuscitator FDA UDI
Generic Name: Pulmonary resuscitator, pneumatic, reusable FDA UDI
Device Name: Puffin Lite Infant Resuscitator FDA UDI
Model / Reference: Puffin FDA UDI
Description: Puffin Lite Infant Resuscitator FDA UDI

Identifiers

Primary DI / UDI-DI: 00865648000344 FDA UDI
510(k) Number: K182956 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Pulmonary resuscitator, pneumatic, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5925 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

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

Category: Pulmonary resuscitator, pneumatic, reusable

Puffin Lite Infant Resuscitator by International Biomedical, Ltd. — 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: International Biomedical, Ltd.

Sources (1)

FDA UDI 1254ea27-1fad-4551-a0f0-0321510fd14d 35 fields · synced Jun 6, 2026