Duns Number:086911794
Device Description: 1- Adhesive Bandage, 7/8” x 3” Strip, 50/box1- Adhesive Bandage, 2” x 3” Patch, 25/box1- A 1- Adhesive Bandage, 7/8” x 3” Strip, 50/box1- Adhesive Bandage, 2” x 3” Patch, 25/box1- Adhesive Tape, Tri-Cut 5yd1- Alcohol Prep Pads, 50/box1- Antiseptic Wipes, 20/box1- Bloodstopper Compress 9” x 5”1- Burn Dressing 4” x 4”1- Cold Pack, Small, Boxed1- CPR Mask/Breathing Barrier1- Eyewash 4oz1- Eyewash 16oz1- Gauze Pad 4” x 4”, Sterile, 10/box1- Gauze Roll 2” x 5yds1- Gauze Roll 4” x 5yds2- Powder Free Exam Gloves, Disposable, Pair/L1- Rescue Blanket, 52” x 84”
Catalog Number
-
Brand Name
Medi-First Plus Standard Trauma First Aid Kit
Version/Model Number
93901
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
ea90cd14-e36e-4999-88e1-f2e11d57d59f
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
50347682939019
Quantity per Package
3
Contains DI Package
00347682939014
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 |