Duns Number:001695568
Device Description: First Aid Kit, First Aid Essentials, 70 items including 1 carrying case: 15 - Fabric Antib First Aid Kit, First Aid Essentials, 70 items including 1 carrying case: 15 - Fabric Antibacterial Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 10 - Fabric Antibacterial Bandages 3/4 IN x 3 IN (19 mm x 76mm); 5 - Fabric Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm); 21 - Sheer Antibacterial Bandages 1 IN x 3 IN (25mm x 76 mm); 6 - Hand Cleansing Wipes 4.75 IN x 7.75 IN (120 mm x 196 mm); 4 - Triple Antibiotic Ointment 1/32 OZ (0.9 g); 8 - Sterile Pads 2 IN x 2 IN (50 mm x 50 mm); 1 - Carrying Case
Catalog Number
-
Brand Name
Exchange Select
Version/Model Number
614299999152
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
243b3384-7b9b-4544-b494-7ec3b0d02d87
Public Version Date
August 18, 2020
Public Version Number
1
DI Record Publish Date
August 10, 2020
Package DI Number
10614299999159
Quantity per Package
36
Contains DI Package
00614299999152
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |