Duns Number:086911794
Device Description: 1- Antiseptic Wipes, 10ct1 -1” x 3” Plastic Strips, 16ct2 -4" x 4" Burn Dressings2 -2" x 6 1- Antiseptic Wipes, 10ct1 -1” x 3” Plastic Strips, 16ct2 -4" x 4" Burn Dressings2 -2" x 6" Burn Dressings1 -4” x 16” Burn Dressing6 -Water Jel Burn Jel 3.5gm Pkts1 -Derma Cool, 2oz Bottle2 -Vinyl Exam Gloves, pr2 -2” Stretch Roller Gauze1 -2” Elastic Wrap w/ Clips1 -1/2” x 5yds Adhesive Tape1 -Scissors, 4.5”6 -Gauze Pads 2” x 2”6 -Gauze Pads 3” x 3”1 -Instruction Sheet
Catalog Number
89611
Brand Name
Medi-First Deluxe Plastic Burn Kit
Version/Model Number
89611
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
Yes
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
OJI
Product Code Name
Burn Kit With Drug
Public Device Record Key
fba91e1c-74fd-489d-808f-182aa8ed719c
Public Version Date
September 10, 2019
Public Version Number
2
DI Record Publish Date
July 19, 2019
Package DI Number
50347682896114
Quantity per Package
10
Contains DI Package
00347682896119
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 |