Duns Number:118492643
Device Description: The Medic Enhancement Set is convenience kit with a capability improvement providing a com The Medic Enhancement Set is convenience kit with a capability improvement providing a combination of advanced tools for the management of massive hemorrhage, airway compromise, respiratory system insults and circulatory compromise. • The set is comprised of color coded MARCH protocol devices for rapid visual identification of the appropriate tool required under the MARCH protocol.• Each set is designed to augment or enhance first respondents treatment capacities.TMT-Tourniquet 2 eaCelox Rapid 2 eaiTClamp 1 eaControl-Cric 1 eaSentinel Chest Seal 2 eaTALON IO Starter Set 1 eaBattle Bandage 2 ea
Catalog Number
82-504-03
Brand Name
Medic Enhancement Set
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
43503066-4f7d-4f2c-a455-a2af91d7d07f
Public Version Date
April 12, 2022
Public Version Number
4
DI Record Publish Date
August 11, 2017
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |