Kroger - Kroger Autolet Lancing Device - KROGER CO., THE

Duns Number:006999528

Device Description: Kroger Autolet Lancing Device

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More Product Details

Catalog Number

-

Brand Name

Kroger

Version/Model Number

AT 0270KRO

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

Yes

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

FMK

Product Code Name

Lancet, Blood

Device Record Status

Public Device Record Key

67a71ce5-268c-4e39-b537-7220c08da2ae

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 11, 2021

Additional Identifiers

Package DI Number

20041260007808

Quantity per Package

20

Contains DI Package

00041260007804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve

"KROGER CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 15