Duns Number:086911794
Device Description: 4 - Medi-Lyte Tablets, 2/pkt2 - Cool Jel 3.5g Pkt2 - Sunscreen Pkt1 - 2” Co-Wrap Bandage2 4 - Medi-Lyte Tablets, 2/pkt2 - Cool Jel 3.5g Pkt2 - Sunscreen Pkt1 - 2” Co-Wrap Bandage2 - Instant Cold Pack, Large1 - Sweat Band2 - Emergency Drinking Water Pkt1 - Silver Rescue Blanket2 - Tempa Dot Thermometers
Catalog Number
740H1SK
Brand Name
Medi-First Heat Relief First Aid Kit
Version/Model Number
740H1SK
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
7742b9a0-4354-4a77-9d3c-f152dbd711e7
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682740455
Quantity per Package
10
Contains DI Package
00347682740450
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 |