Duns Number:063997360
Device Description: First Aid Kit; First Aid Essentials; Pack and Go Convenience; 12 Items and 1 Carrying Case First Aid Kit; First Aid Essentials; Pack and Go Convenience; 12 Items and 1 Carrying Case; 6 Fabric Antibacterial Bandages with First Aid Antiseptic; Active Ingredient: Benzalkonium Chloride 0.1 percent; 2 Hand Cleansing Wipes; 4 Sterile Pads; For External Use Only
Catalog Number
4935516
Brand Name
LEADER
Version/Model Number
4935516
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHO
Product Code Name
First aid kit without drug
Public Device Record Key
1e1937e7-055e-42b5-aac4-34345b91167b
Public Version Date
July 02, 2021
Public Version Number
2
DI Record Publish Date
April 18, 2019
Package DI Number
50096295125554
Quantity per Package
48
Contains DI Package
00096295125559
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |