Kroger - 3-Step Wound Care Kit, 40 items: 10 - Gauze Pad 4 - KROGER CO., THE

Duns Number:006999528

Device Description: 3-Step Wound Care Kit, 40 items: 10 - Gauze Pad 4 IN x 4 IN (101 mm x 101 mm); 10 - Antise 3-Step Wound Care Kit, 40 items: 10 - Gauze Pad 4 IN x 4 IN (101 mm x 101 mm); 10 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 12 - Non-Stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 - Transparent Dressings 2.36 IN x 2.75 IN (59 mm x 69 mm); 3 -Rolled Gauze 4 IN x 2.5 YDS (101 mm x 2.28 m); 1 - Paper Tape 1 IN x 10 YDS (25 mm x 9.14 m)

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More Product Details

Catalog Number

-

Brand Name

Kroger

Version/Model Number

041260381485

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 26, 2021

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRR

Product Code Name

First Aid Kit With Drug

Device Record Status

Public Device Record Key

b2f7ed9b-3d5a-42c1-b3ff-9fee5f77d805

Public Version Date

August 19, 2021

Public Version Number

3

DI Record Publish Date

November 29, 2019

Additional Identifiers

Package DI Number

10041260381482

Quantity per Package

36

Contains DI Package

00041260381485

Package Discontinue Date

February 26, 2021

Package Status

Not in Commercial Distribution

Package Type

case

"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