Duns Number:006959555
Device Description: First Aid Kit, First Aid Essentials, 150 items: 5 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN ( First Aid Kit, First Aid Essentials, 150 items: 5 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 2 - Acetaminophen Tablets (2 per packet); 2 - Aspirin Tablets (2 per packet); 4 - Triple Antibiotic Ointment 1/32 OZ (0.9 g); 1 - Single Use Instant Cold Pack; 2 - Nitrile Exam Gloves; 1 - Set of plastic Tweezers; 1 - Pair of Scissors; 10 - Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 15 - Fabric Adhesive Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 10 - Fabric Adhesive Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 5 - Fabric Adhesive Bandages 1 IN x 3 IN (25 mm x 76 mm); 14 - Sheer Adhesive Bandages 7/8 IN (22 mm); 24 - Sheer Adhesive Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); Sheer Adhesive Bandages 3/4 IN x 3 IN (19 mm x 76 mm); Sheer Adhesive Bandages 2 1/4 IN x 3 IN (57 mm x 76 mm); 6 - Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 2 - Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 1- Rolled Gauze 2 IN x 2 1/2 YDS (50 mm x 2.28 m); 1 – Paper Tape 1/2 IN x 5 YD (12.7 mm x 4.5 m); 1 – First Aid Guide; 1 - Plastic Carrying Case.
Catalog Number
4212608
Brand Name
meijer
Version/Model Number
713733521710
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
c75d9317-a4bd-494f-ac40-0e006b89a539
Public Version Date
December 13, 2019
Public Version Number
2
DI Record Publish Date
July 31, 2019
Package DI Number
10713733521717
Quantity per Package
24
Contains DI Package
00713733521710
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 |