Duns Number:001180207
Device Description: Travel First Aid Kit, Weatherproof Plastic Case, 64 Pieces - Adhesive Fabric Bandages, 1" Travel First Aid Kit, Weatherproof Plastic Case, 64 Pieces - Adhesive Fabric Bandages, 1" x 3" (10); Adhesive Fabric Bandages, 2" x 3" (3); Alcohol Pads (15); Cold Pack, 4" x 5"; Conforming Gauze Roll, 2"; Extra-Strength Non-Aspirin Tablets (4); Fingertip Fabric Bandages (5); First Aid Guide; First Aid Tape, 1/2" x 5 yd; First Aid/Burn Cream Packets (3); Ibuprofen Tablets (4); Knuckle Fabric Bandages (4); Motion Sickness Tablets (Dimenhydrinate) (2); Nitrile Exam Gloves (2); Sterile Gauze Pads, 3" x 3" (2); Sting Relief Wipes (3).
Catalog Number
7107
Brand Name
First Aid Only
Version/Model Number
7107
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"
-
For Single-Use
-
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
097d6971-fa67-4e07-b850-343b579782fc
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
September 17, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 303 |