Silvercrest - Pulse Oximeter intended for wellness use in - LIDL US, LLC

Duns Number:079389709

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

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More Product Details

Catalog Number

453.75

Brand Name

Silvercrest

Version/Model Number

IAN 326857_1901

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PGJ

Product Code Name

Oximeter, Wellness

Device Record Status

Public Device Record Key

191efbf7-d6a9-46e1-b6fa-adb0c0c7938f

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

August 19, 2019

Additional Identifiers

Package DI Number

14056232708224

Quantity per Package

4

Contains DI Package

04056232708227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case pack

"LIDL US, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 11