Duns Number:001180207
Device Description: Heat Stress First Aid Kit, Plastic Case - Contains: Cold Pack, 4" x 5" (4); Disposable Th Heat Stress First Aid Kit, Plastic Case - Contains: Cold Pack, 4" x 5" (4); Disposable Thermometer (5); Electrolyte Drink Mix (10); Electrolyte Tablets (50); Emergency Blanket, 52" x 84"; Waterproof Tape, 1/2" X 5yd (2),
Catalog Number
5250
Brand Name
First Aid Only
Version/Model Number
5250
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
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
d399d793-4970-454f-b5e1-e59f7a8cb889
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
September 18, 2020
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 | 303 |