Flexicare

FDA UDI

Class I (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name: Flexicare FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name: Neonatal Round Resuscitation Mask Size 000 FDA UDI
Model / Reference: 038-53-560U FDA UDI
Description: Neonatal Round Resuscitation Mask Size 000 FDA UDI

Identifiers

Primary DI / UDI-DI: 05055931117476 FDA UDI
FDA Product Code: BYG FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5580 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiopulmonary resuscitation mask, single-use

Flexicare by Flexicare Medical Limited — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Flexicare Medical Limited

Sources (1)

FDA UDI 82a71d79-cd04-42a7-afa3-dd217767d958 33 fields · synced May 30, 2026