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)
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
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
LRR
Product Code Name
First Aid Kit With Drug
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
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
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 |