Duns Number:086911794
Device Description: 1 Adhesive Bandage 1” x 3” Plastic Strip, 16/box1 Adhesive Bandage 1” x 3” Woven Strip, 16 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
917M1
Brand Name
Medi-First Plus Standard Vehicle Metal First Aid Kit
Version/Model Number
917M1
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
25e45fb9-0387-49e1-b377-f1804ad8d063
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682917017
Quantity per Package
12
Contains DI Package
00347682917012
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 |