Duns Number:118492643
Device Description: 1 - TMT-Tourniquet1 - Celox RAPID B-Con1 - Positional Airway Card2 - Sentinel Chest Seal1 1 - TMT-Tourniquet1 - Celox RAPID B-Con1 - Positional Airway Card2 - Sentinel Chest Seal1 - Emergency Bandage1 - Blizzard IFAK Blanket2 - Exam Gloves1 - Quick Reference Guide
Catalog Number
SDR-VSIP-OTC
Brand Name
Medical Trauma Kit Individual Trauma Kit OTC
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 02, 9999
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
ca53d7f2-36d1-4eb1-8977-36fef1d53b37
Public Version Date
June 13, 2022
Public Version Number
1
DI Record Publish Date
June 03, 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 |