Duns Number:118492643
Device Description: TMT - Tourniquet 4 eaCelox RAPID 4 eaControl-Cric 1 eaigel SGA (Size 5) 1 eaNasal Airw TMT - Tourniquet 4 eaCelox RAPID 4 eaControl-Cric 1 eaigel SGA (Size 5) 1 eaNasal Airway 3 eaSentinel Chest Seal 6 eaDart 14g Needle/Catheter 3 eaTALON IO Start Set 1 eaBattle Bandage 3 eaHAWK Advanced Hypothermia Management Set 1 eaEye Shield 2 eaTrauma Shears 1 eaTCCC Card (DD-1380) 2 eaPermanent Marker 1 eaRXONLY
Catalog Number
82-504-05
Brand Name
MEDIC ENHANCEMENT RESUPPLY
Version/Model Number
03
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"
Yes
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
a74dd481-c2da-4e67-87b1-5059f65d8bb4
Public Version Date
April 12, 2022
Public Version Number
2
DI Record Publish Date
October 08, 2019
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 |