Kroger - KROGER INFRARED THERMOMETER MULTIFUNCTION - KROGER CO., THE

Duns Number:006999528

Device Description: KROGER INFRARED THERMOMETER MULTIFUNCTION

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More Product Details

Catalog Number

112-935-000

Brand Name

Kroger

Version/Model Number

112-935-000

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100488,K100488,K100488

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

3f81e0a9-f065-4c4e-99cf-c34b5073dd8a

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

July 18, 2016

Additional Identifiers

Package DI Number

10041260367066

Quantity per Package

4

Contains DI Package

30041260367060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton

"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