Duns Number:086911794
Device Description: 15 Adhesive Bandages 3/4 in x 3 in10 Adhesive Bandages 3/8 in x 1-1/2 in4 Butterfly Closur 15 Adhesive Bandages 3/4 in x 3 in10 Adhesive Bandages 3/8 in x 1-1/2 in4 Butterfly Closures1 Knuckle Bandage1 Adhesive Tape Roll 1/2 in x 5 yd10 Cotton Tip Applicators2 Finger Splints1 Accident Report Form1 First Aid Instruction Guide4 Sterile Gauze Pads 2 in x 2 in2 Sterile Gauze Pads 4 in x 4 in1 Gauze Roll 2 in x 4.1 yd2 Examination Gloves2 Non-Aspirin (4 tabs)
Catalog Number
40088
Brand Name
Medi-First 88 Piece Auto/Travel Kit
Version/Model Number
40088
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
-
Product Code Name
-
Public Device Record Key
bd76395a-4233-4e60-b58a-a1818b105401
Public Version Date
September 06, 2021
Public Version Number
2
DI Record Publish Date
July 24, 2019
Package DI Number
50347682400885
Quantity per Package
12
Contains DI Package
00347682400880
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 |