Duns Number:086911794
Device Description: 1 Adhesive Bandage 1” x 3” Strip, 100/box1 Adhesive Bandage, 7/8” x 3” Strip, 50/box1 Adhe 1 Adhesive Bandage 1” x 3” Strip, 100/box1 Adhesive Bandage, 7/8” x 3” Strip, 50/box1 Adhesive Bandage, Fingertip, 40/box1 Adhesive Bandage, Knuckle, 40/box1 Adhesive Tape, Tri-Cut 5yd1 Alcohol Prep Pads, 50/box1 Ammonia Wipes, 10/box1 Antacid Tablets, 250/box1 Antiseptic Spray 2oz Pump1 Antiseptic Wipes-XL, 20/box1 Bloodstopper Compress 9” x 5”1 Burn Gel Unit Dose 1/8oz pkt2 Burn Dressing 4” x 4”1 Burn Spray 2oz Pump2 Cold Pack, Small, Boxed2 Cotton Tip 3” Applicator, 10/bag1 CPR Mask/Breathing Barrier4 Eye Pads1 Eyewash 4oz1 First Aid Handbook1 Gauze Pad 3” x 3”, Sterile, 25/box2 Gauze Roll 2” x 5yds1 Gauze Roll 4” x 5yds1 Hand Sanitizer, 10/bag10 Non-Adherent Sterile Pads 2” x 3” Sterile1 Pain Relief Tablets, 250/box4 Powder Free Exam Gloves, Disposable, Pair/L1 Scissors 4.5”1 Splint, Multi-Purpose1 Tourniquet4 Trauma Pads 5” x 9”2 Triangular Bandage with Pins, Non-Sterile1 Triple Antibiotic Ointment, 25/box1 Tweezers, Plastic, Disposable
Catalog Number
964M1
Brand Name
Medi-First Plus 3-Shelf Metal First Aid Cabinet
Version/Model Number
964M1
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
4050581b-e75c-4d62-8019-9630055f030f
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 |