Pocket Mask O2, SP Black Private Label

FDA UDI

Class I (US FDA UDI)

by Laerdal Medical Corp.

Identity

Trade Name: Pocket Mask O2, SP Black Private Label FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, reusable FDA UDI
Device Name: The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the rescuer and patient. The Pocket Mask with Oxygen Inlet can be connected to an external Oxygen source. FDA UDI
Model / Reference: 839922 FDA UDI
Description: The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the rescuer and patient. The Pocket Mask with Oxygen Inlet can be connected to an external Oxygen source. FDA UDI

Identifiers

Catalog Number: 839922 FDA UDI
Primary DI / UDI-DI: 07045432119213 FDA UDI
FDA Product Code: KGB FDA UDI
CBP FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5570 FDA UDI
868.5870 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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Contains Latex

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Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Cardiopulmonary resuscitation mask, reusable

Pocket Mask O2, SP Black Private Label by Laerdal Medical Corp. — 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: Laerdal Medical Corp.

Sources (1)

FDA UDI 867a289c-8503-440d-af3d-74b04ce00d2e 36 fields · synced Jun 8, 2026