BM-02

Organization name

JABLOTRON a.s.

SRN

CZ-MF-000033469

Manufacturer status

Active

Primary placement in Czechia; available across 10 countries total.

Trade name

not provided

UDI-DI code

08594052530056

Basic UDI-DI

B-08594052530056

Reference / catalog number

BM-02

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The BM-02 Baby breathing monitor is a certified Class IIb medical device that monitors a baby’s breathing. It cannot be used to restore vital functions and is not a therapeutic device. It does not replace proper childcare. It is intended for use by health care providers and for care in the home environment. The product is intended to provide a warning, by an optical and acoustic warning, that the respiration has stopped or the respiration rate has decreased. It thus warns of the possible danger of respiratory arrest that may occur in young infants (for example, due to sudden infant death syndrome - SIDS) or due to other causes (suffocation, an illness, etc.). Due to the nature and purpose of use, no side effects and other contraindications are known.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12080406APNOEA MONITORS

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• Expiration date
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