Duns Number:006959555
Device Description: First Aid Kit, Pack-&-Go Convenience, 30 items + carrying case: 2 - Waterproof Bandages 3/ First Aid Kit, Pack-&-Go Convenience, 30 items + carrying case: 2 - Waterproof Bandages 3/4 IN x 2 IN (19 mm x 50 mm); 4 - Fabric Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 6 - Sheer Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 4 - Sheer Bandages 1 IN x 3 IN (25 mm x 76 mm); 4 - Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 4 - Sheer Bandages 7/8 IN (22 mm); 2 - Hand Cleansing Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 2 - Triple Antibiotic Ointment 1/32 OZ (0.9 g); 2 - Gauze Pads 2 IN x 2 IN (50 mm x 50 mm)
Catalog Number
4323804
Brand Name
meijer
Version/Model Number
719283515964
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
f209e8c0-1c31-476d-a33d-1c4e65f967ad
Public Version Date
December 13, 2019
Public Version Number
2
DI Record Publish Date
July 30, 2019
Package DI Number
10719283515961
Quantity per Package
48
Contains DI Package
00719283515964
Package Discontinue Date
-
Package Status
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |