Duns Number:086911794
Device Description: 1 Adhesive Bandage 1” x 3” Strip, 100/box1 Adhesive Tape, 1/2” x 5yd1 Antiseptic Spray 2oz 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
887ANSI
Brand Name
Medi-First 50 Person Class B Metal First Aid Kit
Version/Model Number
887ANSI
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
795efba6-80ae-48d5-b8d5-281082d90612
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682887242
Quantity per Package
6
Contains DI Package
00347682887247
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 |