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 6+ Patient Hard Case Advanced Bleeding Control Kit / with extra Hemostatic Gauze
Catalog Number
-
Brand Name
EMPACT Active Shooter Tool Kit Advanced Bleeding Control Kit- 6+ Patient HC
Version/Model Number
B283E6HCXPB0
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OVR
Product Code Name
Kit, First Aid, Talking
Public Device Record Key
91ca1f73-0b2b-4a45-b500-ae1894f2c435
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 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 |