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

Pad, Heating, Powered (IRT) (4) Analyzer, Body Composition, Exempt (PUH) (2) Thermometer, Electronic, Clinical (FLL) (2) Oximeter, Wellness (PGJ) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1)

Premarket Exempt

No Yes

Clear

Silvercrest - 04055334216562 Catalog Number : 218.63

Device Description : SSHK60E5 Neck and Shoulder Heating Pad (Grey)Art No. 218.63IAN 353729_2010 - SSHK 60 E5

Device Class : 2

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Silvercrest - 04055334216579 Catalog Number : 218.63

Device Description : SSHK60E5 Neck and Shoulder Heating Pad (Beige)Art No. 218.63IAN 353729_2010 - SSHK 60 E5

Device Class : 2

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Silvercrest - 04055334329453 Catalog Number : 760.62

Device Description : Digital Body Composition Scale SBF77 (Black)

Device Class : 2

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Silvercrest - 04055334329460 Catalog Number : 760.63

Device Description : Digital Body Composition Scale SBF77 (White)

Device Class : 2

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Silvercrest - 04055334329484 Catalog Number : 653.18

Device Description : Bluetooth Blood Pressure Monitor (SBM69)Upper-arm blood pressure monitor intende Bluetooth Blood Pressure Monitor (SBM69)Upper-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 :

Duns Number: 079389709

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Silvercrest - 04055334330084 Catalog Number : 793.99

Device Description : SFT81Multi-Purpose Thermometer

Device Class :

Duns Number: 079389709

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Silvercrest - 04055334330404 Catalog Number : 454.12

Device Description : SPO55 Pulse Oximeter intended for wellness use in measuring the blood oxygen sat SPO55 Pulse Oximeter intended for wellness use in measuring the blood oxygen saturation and the heart rate (pulse rate).

Device Class :

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : PGJ

Prescription Use : No

Device Count : 1

Silvercrest - 04055334351188 Catalog Number : 238.19

Device Description : SWKK60A1 Heated CushionArt. No. 238.19IAN 387487_2101

Device Class : 2

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Silvercrest - 04055334351195 Catalog Number : 238.20

Device Description : SKH60A Heat PadArt. No. 238.20IAN 387488_2101

Device Class : 2

Duns Number: 079389709

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Silvercrest - 04056232708203 Catalog Number : 793.86

Device Description : 6-in-1 Multi-functional ThermometerInfrared Ear/Forehead Thermometer intended fo 6-in-1 Multi-functional ThermometerInfrared Ear/Forehead Thermometer intended for the intermittent measurement of human body temperature by people of all ages. Device is reusable and for home use only.

Device Class : 2

Duns Number: 079389709

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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