Duns Number:001180207
Device Description: 10 Person Vehicle First Aid Kit, Weatherproof Steel Case - Contains: Adhesive Plastic Ba 10 Person Vehicle First Aid Kit, Weatherproof Steel Case - Contains: Adhesive Plastic Bandages, 1" x 3" (16); Alcohol Pads (30); Conforming Gauze Roll, 4"; Eyewash, 1 oz; First Aid Guide; First Aid Tape, 1/2" x 5 yd; First Aid/Burn Cream Packets (6); Nitrile Exam Gloves (4); Scissors; Sterile Eye Pads and Strips (2); Sterile Gauze Pads, 3" x 3" (4); Trauma Pad, 5" x 9"; Triangular Bandage, 40" x 40" x 56"; Triple Antibiotic Ointment Packets (6); Tweezers.
Catalog Number
6400
Brand Name
First Aid Only
Version/Model Number
6400
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
7fc25e0a-93d0-4721-9511-2b52770aaecb
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
September 16, 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 |