Duns Number:118492643
Device Description: MARCH IFAK RESUPPLYTMT Tourniquet 1 eaCelox Rapid 1 eaNasal Trumpet MARCH IFAK RESUPPLYTMT Tourniquet 1 eaCelox Rapid 1 eaNasal Trumpet 1 eaSentinel Chest Seal 1 eaDart 14g Needle/Catheter 1 eaBattle Bandage 1 eaRolled Gauze 1 eaEye Shield 1 eaGloves (Pair) 1 eaTCCC Card (DD-1380) 1 eaPermanent Marker 1 eaQuick Start Guide 1 ea
Catalog Number
81-303-01
Brand Name
MARCH IFAK RESUPPLY
Version/Model Number
04
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
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
LRR
Product Code Name
First Aid Kit With Drug
Public Device Record Key
0f536ae6-c58b-4c13-bf60-9fc64ebb94b7
Public Version Date
April 12, 2022
Public Version Number
2
DI Record Publish Date
July 02, 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 |