Duns Number:827067880
Device Description: EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Tra EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Trauma First Aid Bleeding Control Kit - 6+ Patient Hard Case with Tactical
Catalog Number
-
Brand Name
EMPACT Active Shooter Tool Kit- Bleeding Control 6+ Patient Hard Case Kit
Version/Model Number
B283E6HCXOE0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
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
ac050ed6-209b-492a-adf0-5d574e636336
Public Version Date
October 26, 2018
Public Version Number
1
DI Record Publish Date
September 25, 2018
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 | 29 |