Duns Number:118492643
Device Description: TMT - Tourniquet 4 eaCelox RAPID 4 eaControl-Cric 1 eaigel SGA (Size 5) 1 eaNasal Trum TMT - Tourniquet 4 eaCelox RAPID 4 eaControl-Cric 1 eaigel SGA (Size 5) 1 eaNasal Trumpet 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-1300 2 eaPermanent Marker 1 eaRXONLY
Catalog Number
82-504-05
Brand Name
MEDIC ENHANCEMENT RESUPPLY
Version/Model Number
00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 08, 2018
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"
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
d1aace2e-0b98-40bb-8566-c415e1746abd
Public Version Date
April 12, 2022
Public Version Number
3
DI Record Publish Date
April 11, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |