Duns Number:118492643
Device Description: (1) TMT (Tactical Mechanical Tourniquet)(1) Celox B-Con(1( Swat-T Orange(2) TACGAUZE(1) Em (1) TMT (Tactical Mechanical Tourniquet)(1) Celox B-Con(1( Swat-T Orange(2) TACGAUZE(1) Emergency Blanket(1) Pair Vinyl Gloves(1) Klever Kutter (1) Emergency Instructions
Catalog Number
SH-START-PAX-SM
Brand Name
SCHOOL TRAUMA ADVANCED RESPONSE KIT
Version/Model Number
01
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)
-
Over the Counter (OTC)
Yes
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
b133b21e-0f7b-40f7-97fe-76b281dc8147
Public Version Date
October 04, 2022
Public Version Number
1
DI Record Publish Date
September 26, 2022
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 |