Duns Number:086911794
Device Description: 6 Adhesive Bandage, 7/8” x 3” Strip2 Adhesive Bandage, 2” x 3” Patch2 Adhesive Bandage, Kn 6 Adhesive Bandage, 7/8” x 3” Strip2 Adhesive Bandage, 2” x 3” Patch2 Adhesive Bandage, Knuckle1 Adhesive Tape 1/2” x 2.5yds8 Alcalak Tablets, 2pk6 Antiseptic Towelettes8 APAP XS Tablets, 2pk4 Butterfly Bandage, Large8 CCP Caffeine Free Tablets, 2pk4 Chlorphen Tablets, 2pk8 Diamode Tablets, 1pk12 Decorel Forte Plus, 2pk16 Diotame Tablets, 2pk1 Elastic Wrap w/ Clips 2”1 Elastic Wrap w/ Clips 4”1 Eye Wash, 1oz4 Gauze Pad 4” x 4”, Sterile1 Gauze Roll 3” x 5yds2 Hydrocortisone Cream, 1gm2 Insect Sting Relief Wipes2 Iodine Swabs8 I-Prin Tablets, 2pk6 Medikoff Drops1 Powder Free Exam Gloves, Disposable, Pair/L2 Thermometer, Disposable Forehead1 Traveler Advice Card1 Triangular Bandage with Pins, Non-Sterile2 Triple Antibiotic Ointment, .5g2 Safety Pins1 Scissors,
Catalog Number
77501
Brand Name
Medi-First Interational Traveler First Aid Kit
Version/Model Number
77501
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
866d20e9-72ff-4099-901c-2bd7f6496ff4
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |