Duns Number:086911794
Device Description: 30 - Adhesive Bandages 1 in x 3 in20 - Adhesive Bandages 3/8 in x 1-1/2 in1 - Adhesive Tap 30 - Adhesive Bandages 1 in x 3 in20 - Adhesive Bandages 3/8 in x 1-1/2 in1 - Adhesive Tape Roll 1/2 in x 5 yd1 - Triangular Bandage 40 in x 40 in x 56 in10 - Cotton Tip Applicators2 - Finger Splints1 - First Aid Instruction Guide4 - Sterile Gauze Dressing 2 in x 2 in4 - Sterile Gauze Dressing 4 in x 4 in1 - Sterile Trauma Pad 5 in x 9 in1 - Gauze Roll 2 in x 4.1 yd4 - Examination Gloves1 - Instant Cold Compress5 - Burn Cream Packets6 - Antibiotic Ointment Packets12 - Alcohol Prep Pads3 - Sting Relief Pads12 - Antiseptic Towelettes1 - Metal Scissors1 – Tweezers
Catalog Number
40120
Brand Name
Medi-First 120 Piece Multi-Purpose Kit
Version/Model Number
40120
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
41f134c0-d1d8-401b-b60f-7778fa8354a3
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682401202
Quantity per Package
12
Contains DI Package
00347682401207
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 |