Duns Number:827067880
Device Description: EMPACT 6+ Patient Hard Case Kit with Wall Cabinet OTC - Tactical & Medical Kit. Tactical EMPACT 6+ Patient Hard Case Kit with Wall Cabinet OTC - Tactical & Medical Kit. Tactical side has Bat Flash Light, TAC-WEGE, TAC-KEYS and other Tactical components that can be used in an active shooter RUN, HIDE, Fight situation. Medical side has bleeding control Kits featuring Hemostatic Dressing and other Trauma First- Aid equipment.
Catalog Number
-
Brand Name
EMPACT 6+ Patient Hard Case Kit with Wall Cabinet OTC
Version/Model Number
B283E6HCXOB0
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)
-
Over the Counter (OTC)
Yes
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
ad25cc4b-7b42-45fc-bad1-202bd7cd39a7
Public Version Date
June 04, 2021
Public Version Number
1
DI Record Publish Date
May 27, 2021
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 |