Duns Number:086911794
Device Description: 6 - Adhesive Bandage, 7/8” x 3” Strip2 - Adhesive Bandage, 2” x 3” Patch2 - Adhesive Banda 6 - Adhesive Bandage, 7/8” x 3” Strip2 - Adhesive Bandage, 2” x 3” Patch2 - Adhesive Bandage, Knuckle8 - Alcalak Tablets, 2pk6 - Antiseptic Towelettes8 - APAP XS Tablets, 2pk8 - CCP Caffeine Free Tablets, 2pk4 - Chlorphen Tablets, 2pk4 - Diamode Tablets, 1pk12 - Decorel Forte Plus, 2pk8 - Diotame Tablets, 2pk1 - Eye Wash, 1oz2 - Hydrocortisone Cream, 1gm2 - Insect Sting Relief Wipes8 - I-Prin Tablets, 2pk6 - Medikoff Drops1 - Powder Free Exam Gloves, Disposable, Pair/L2 - Thermometer, Disposable Forehead1 - Traveler Advice Card2 - Triple Antibiotic Ointment, .5g2 - Safety Pins1 - Scissors, 4-1/2”
Catalog Number
76301B
Brand Name
Medi-First Heathy Traveler First Aid Kit
Version/Model Number
76301B
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
d1d0a190-d72a-4f4e-b14e-47366e360b15
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
50347682763010
Quantity per Package
12
Contains DI Package
00347682763015
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 |