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Rescuer Disposable Resuscitation Cushion Mask (#1 Infant)

FDA UDI

Class I (US FDA UDI)

by B.L.S. Systems Limited

Identity

Trade Name
Rescuer Disposable Resuscitation Cushion Mask (#1 Infant) FDA UDI
Generic Name
Resuscitator face mask, single-use FDA UDI
Device Name
Rescuer Disposable Resuscitation Cushion Mask (#1 Infant) FDA UDI
Model / Reference
1520 FDA UDI
Description
Rescuer Disposable Resuscitation Cushion Mask (#1 Infant) FDA UDI

Identifiers

Catalog Number
1520 FDA UDI
Primary DI / UDI-DI
B00215200 FDA UDI
FDA Product Code
BSJ FDA UDI
GMDN Term
Resuscitator face mask, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5550 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Resuscitator face mask, single-use

Rescuer Disposable Resuscitation Cushion Mask (#1 Infant) by B.L.S. Systems Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resuscitator face mask, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B.L.S. Systems Limited

Sources (1)

  • FDA UDI 4ffaf7ea-97ce-4370-89c7-abd88298dd07 36 fields · synced May 30, 2026