Duns Number:006959555
Device Description: First Aid Kit, First Aid Essentials, 70 items + 1 carrying case: 4 -Triple Antibiotic Oint First Aid Kit, First Aid Essentials, 70 items + 1 carrying case: 4 -Triple Antibiotic Ointment 1/32 OZ (0.9 g); 8 - Sterile Pads 2 IN x 2 IN (50 mm x 50 mm); 6 - Hand Cleansing Wipes 4.75 IN x 7.75 IN (120 mm x 196 mm); 5 - Fabric Bandages 1 IN x 3 IN (25 mm x 76 mm); 10 - Fabric Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 15 - Fabric Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 21 - Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 1 - Paper Tape 1/2 IN x 5 YD (12 mm x 4.5 m).
Catalog Number
4212609
Brand Name
meijer
Version/Model Number
713733521703
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
cc9cc850-7a5b-45d0-8382-8eca0b454b2b
Public Version Date
August 05, 2020
Public Version Number
3
DI Record Publish Date
July 31, 2019
Package DI Number
10713733521700
Quantity per Package
36
Contains DI Package
00713733521703
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 |