Duns Number:086911794
Device Description: 1 - Adhesive Bandage 1” x 3” Strip, 100/box1 - Adhesive Tape, 1/2” x 5yd1 - Antiseptic Spr 1 - Adhesive Bandage 1” x 3” Strip, 100/box1 - Adhesive Tape, 1/2” x 5yd1 - Antiseptic Spray 2oz Pump2- Burn Dressing 4” x 4”1 - Burn Spray 2oz Pump2 - Cold Pack, Small, Boxed1 - CPR Mask/Breathing Barrier4 - Eye Pads1 - Eyewash 4oz1 - First Aid Handbook4 - Gauze Pad 3” x 3”, Sterile2 - Gauze Roll 2” x 5yds1 - Gauze Roll 4” x 5yds1 - Hand Sanitizer, 10/bag4 - 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 - ANSI Sticker
Catalog Number
-
Brand Name
Medi-First 50 Person Plastic First Aid Kit
Version/Model Number
807P50P
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
505beab5-6404-4a30-ade1-2e2b358511ee
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
50347682807509
Quantity per Package
6
Contains DI Package
00347682807504
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 |