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Infant Single Use Resuscitator + Pressure Relief 40cmH20 + Mask Size 1 + Mask Si

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
Infant Single Use Resuscitator + Pressure Relief 40cmH20 + Mask Size 1 + Mask Si FDA UDI
Generic Name
Pulmonary resuscitator, manual, single-use FDA UDI
Model / Reference
038-73-940U FDA UDI

Identifiers

Primary DI / UDI-DI
05055788770299 FDA UDI
FDA Product Code
BTM FDA UDI
GMDN Term
Pulmonary resuscitator, manual, single-use 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pulmonary resuscitator, manual, single-use

Infant Single Use Resuscitator + Pressure Relief 40cmH20 + Mask Size 1 + Mask Si by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Pulmonary resuscitator, manual, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flexicare Medical Limited

Sources (1)

  • FDA UDI e2af6561-1f0a-4623-93e5-854b79037f31 32 fields · synced Jun 1, 2026