Duns Number:006999528
Device Description: First Aid Kit, All-Purpose First Aid Essentials, 70 items: 1 - Carrying Case, 4 - Triple A First Aid Kit, All-Purpose First Aid Essentials, 70 items: 1 - Carrying Case, 4 - Triple Antibiotic Ointment 1/32 OZ (0.9 g); 8 - Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 5 - Antibacterial Fabric Bandages 1 IN x 3 IN (25 mm x 76 mm); 10 - Antibacterial Fabric Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 15 - Antibacterial Fabric Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 21 - Antibacterial Sheer Bandages 1 IN x 3 IN (25 mm x 76 mm); 6 - Hand Cleansing Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm)
Catalog Number
-
Brand Name
Kroger
Version/Model Number
041260369728
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 20, 2020
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
1dbed24b-77c0-40a1-87e0-65af9363c089
Public Version Date
September 04, 2020
Public Version Number
2
DI Record Publish Date
November 29, 2019
Package DI Number
10041260369725
Quantity per Package
36
Contains DI Package
00041260369728
Package Discontinue Date
March 20, 2020
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 |