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Laerdal Pocket Mask

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 820050Model Paediatric Pocket Mask

by Laerdal Medical AS

Identity

Trade Name
Laerdal Pocket Mask EUDAMED
Paediatric Pocket Mask CPR Barrier Device FDA UDI
Generic Name
Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name
Paediatric Pocket Mask EUDAMED
The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant. FDA UDI
Model / Reference
Paediatric Pocket Mask EUDAMED
820050 EUDAMEDFDA UDI
Description
The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant. FDA UDI

Identifiers

Catalog Number
820050 FDA UDI
Primary DI / UDI-DI
07045430011557 EUDAMEDFDA UDI
Basic UDI-DI
0704543209938T9 EUDAMED
Direct Marketing DI
07045430011557 EUDAMED
510(k) Number
K023805 FDA UDI
FDA Product Code
CBP FDA UDI
EMDN Code
R03010199 VENTILATION MASKS - OTHER EUDAMED
GMDN Term
Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
868.5870 FDA UDI
Market of Registration
Norway EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Laerdal Pocket Mask by Laerdal Medical AS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laerdal Medical AS
EUDAMED SRN
NO-MF-000000012

Sources (2)

  • EUDAMED 8568bb4f-15e0-4fbc-b548-1cdc0fb3cf03 61 fields · synced Jul 12, 2026
  • FDA UDI caeac4ff-246f-45d8-86b0-1ce032d6de28 37 fields · synced May 30, 2026