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Newborn Masks

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 84615601Model Newborn MaskRef 856157

by Laerdal Medical AS

Identity

Trade Name
Newborn Masks EUDAMED
Newborn Mask - Size 0 Qty 10 - Snap Design FDA UDI
Generic Name
Resuscitator face mask, reusable FDA UDI
Device Name
Newborn Mask EUDAMED
Newborn Masks are intended for face mask ventilation of newborns and infants. FDA UDI
Model / Reference
Newborn Mask EUDAMED
84615601 EUDAMEDFDA UDI
856157 EUDAMED
Description
Newborn Masks are intended for face mask ventilation of newborns and infants. FDA UDI

Identifiers

Catalog Number
84615601 FDA UDI
Primary DI / UDI-DI
07045432087321 EUDAMEDFDA UDI
07045432061758 EUDAMED
Basic UDI-DI
0704543209949TE EUDAMED
Direct Marketing DI
07045432087321 EUDAMED
07045432061758 EUDAMED
FDA Product Code
BYG FDA UDI
EMDN Code
R03010199 VENTILATION MASKS - OTHER EUDAMED
GMDN Term
Resuscitator face mask, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
868.5580 FDA UDI
Market of Registration
Norway EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Newborn Masks by Laerdal Medical AS — Class IIa — 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 (3)

  • EUDAMED 2c1855f9-14c6-4563-bb13-95f212d5a64d 61 fields · synced Aug 1, 2026
  • EUDAMED 0cba7b42-1b3e-4781-bd39-022a937fd3b4 61 fields · synced May 18, 2026
  • FDA UDI f3744da1-b682-4e5e-976a-8fba12fd1a44 37 fields · synced May 29, 2026