LIDL US, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tampon, Menstrual, Unscented (HEB) (3) Oximeter, Wellness (PGJ) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) Toothbrush, Powered (JEQ) (1)

Premarket Exempt

No Yes

Clear

Silvercrest - 04056232708210 Catalog Number : 659.59

Device Description : Bluetooth Blood Pressure MonitorUpper-arm blood pressure monitor intended to mea Bluetooth Blood Pressure MonitorUpper-arm blood pressure monitor intended to measure and monitor the arterial blood pressure values and the heart rates of adults with an arm circumference of 8.7 in to16.5 in (22cm to 42cm), in a non-invasive way.

Device Class : 2

Duns Number: 079389709

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Silvercrest - 04056232708227 Catalog Number : 453.75

Device Description : Pulse Oximeter intended for wellness use in measuring the blood oxygen saturatio Pulse Oximeter intended for wellness use in measuring the blood oxygen saturation and the heart rate (pulse rate).

Device Class : 2

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : PGJ

Prescription Use : No

Device Count : 1

Tampons by Lidl - 04056489267393 Catalog Number :

Device Description : Multi pack of 36 - 18 Regular/18 Super

Device Class : 2

Duns Number: 079389709

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 1

Lidl - 04056489309680 Catalog Number :

Device Description : Power Toothbrush with Replacement Head

Device Class : 1

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 1

Tampons by Lidl - 04056489466642 Catalog Number :

Device Class : 2

Duns Number: 079389709

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 36

Tampons by Lidl - 04056489466659 Catalog Number :

Device Class :

Duns Number: 079389709

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 36

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