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Newborn Mask - Size 1

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 856157-1Model Newborn Mask

by Laerdal Medical AS

Identity

Trade Name
Newborn Mask - Size 1 EUDAMED
Newborn Mask - Size 1 Qty 1 - Snap Design (US) 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. Ref 10-pack cases Models: 84615701, LGH-84615701 FDA UDI
Model / Reference
Newborn Mask EUDAMED
856157-1 EUDAMEDFDA UDI
Description
Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615701, LGH-84615701 FDA UDI

Identifiers

Catalog Number
856157-1 FDA UDI
Primary DI / UDI-DI
07045432112399 EUDAMEDFDA UDI
Basic UDI-DI
0704543209949TE EUDAMED
Direct Marketing DI
07045432112399 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
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 Mask - Size 1 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 (2)

  • EUDAMED f14ae2e8-6138-41b6-8344-6797b1f93c92 61 fields · synced Jun 18, 2026
  • FDA UDI 5f38a43e-b42e-40ea-bd22-a3875d2c2b75 36 fields · synced May 30, 2026