Duns Number:827067880
Device Description: EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical T EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Trauma, First Aid, Bleeding Control 6+ Patient Refurbished Kit with Tactical. Specialized refurbish kit to convert our 10+ Patient Kit into a 6+ Patient Hard Case.
Catalog Number
-
Brand Name
EMPACT 6+ Patient Hard Case Refurbish Kit
Version/Model Number
B283E6HCXPAC
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
-
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
3aa12a35-768e-4014-aa91-d62c88746dd9
Public Version Date
November 10, 2020
Public Version Number
1
DI Record Publish Date
November 02, 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 | 29 |