Duns Number:086911794
Device Description: 16 Adhesive Bandage 1” x 3” Strip*1 Adhesive Tape, 1/2” x 2. 5yd*3 Ammonia Wipes*10 Antise 16 Adhesive Bandage 1” x 3” Strip*1 Adhesive Tape, 1/2” x 2. 5yd*3 Ammonia Wipes*10 Antiseptic Wipes-XL*12 Aspirin Tablets, 2/pkt***10 Burn Cream w/Lidocaine*1 Burn Dressing 4” x 4”1 Cold Pack, Small*1 CPR Mask/Breathing Barrier**2 Eye Pads*1 Eyewash 1oz**1 First Aid Handbook*1 Gauze Pad 4” x 4”, Sterile***4 Gauze Pad 3” x 3”, Sterile**2 Gauze Roll 2” x 5yds*1 Hand Sanitizer, 6/bag**3 Insect Sting Relief Wipes*2 Powder Free Exam Gloves, Disposable, Pair/L*1 Scissors 4.5”*2 Trauma Pads 5” x 9”*1 Triangular Bandage with Pins*10 Triple Antibiotic Ointment**1 Tweezers, Plastic, Disposable*
Catalog Number
821ANSI
Brand Name
Medi-First 10 Person Metal First Aid Kit
Version/Model Number
821ANSI
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
17713089-5ec6-4cd3-a622-b3ed391162a8
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682821246
Quantity per Package
12
Contains DI Package
00347682821241
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 |