Duns Number:086911794
Device Description: 16- Adhesive Bandage 1” x 3” Strip8- Adhesive Bandage, Fingertip8- Adhesive Bandage, Knuck 16- Adhesive Bandage 1” x 3” Strip8- Adhesive Bandage, Fingertip8- Adhesive Bandage, Knuckle1- Adhesive Tape, 1/2” x 2. 5yd3- Ammonia Wipes10- Antiseptic Wipes-XL12- Aspirin Tablets, 2/pkt10- Burn Cream w/Lidocaine1- Burn Dressing 4” x 4”1-- Cold Pack, Small1 CPR Mask/Breathing Barrier2- Eye Pads1- Eyewash 1oz1-- First Aid Handbook4 Gauze Pad 3” x 3”, Sterile2-- Gauze Pad 4” x 4”, Sterile2- Gauze Roll 2” x 5yds1- Hand Sanitizer, 6/bag3- Insect Sting Relief Wipes2- Powder Free Exam Gloves, Disposable, Pair/L1- Scissors 4.5”2- Trauma Pads 5” x 9”1- Triangular Bandage with Pins10- Triple Antibiotic Ointment1 Tweezers, Plastic, Disposable
Catalog Number
818ANSI
Brand Name
Medi-First 25 Person ANSI First Aid Kit
Version/Model Number
818ANSI
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
d37e1528-7000-48d3-b6ca-25c6ce647fa1
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
50347682818246
Quantity per Package
12
Contains DI Package
00347682818241
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 |