Duns Number:086911794
Device Description: 1- Adhesive Bandage 1” x 3” Plastic Strip, 16/box1- Adhesive Bandage 1” x 3” Woven Strip, 1- Adhesive Bandage 1” x 3” Plastic Strip, 16/box1- Adhesive Bandage 1” x 3” Woven Strip, 16/box10- Adhesive Bandage, Fingertip8- Adhesive Bandage, Knuckle1- Adhesive Tape, 1/2” x 5yd2- Ammonia Wipes1- Antiseptic Spray 2oz Pump4- Antiseptic Wipes3- Aspirin Tablets, 2/pk1- Cold Pack, Small1- Eyewash 4oz1- First Aid Handbook6- Gauze Pad 2” x 2”, Sterile1- Gauze Roll 2” x 5yds2- Powder Free Exam Gloves, Disposable, Pair/L1- Scissors 4.5”1- Triangular Bandage with Pins, Non-Sterile1- Tweezer, Plastic, Disposable
Catalog Number
818M1
Brand Name
Medi-First Standatd Vehicle Metal First Aid Kit
Version/Model Number
818M1
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
f1a5878e-0bf9-4bf4-877b-a3e501fa6b14
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
50347682818017
Quantity per Package
12
Contains DI Package
00347682818012
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |