Duns Number:827067880
Device Description: PRO1TEK Medical Trauma First Aid Bleeding Control Kit- 1+ Patient with SWAT Tourniquet - PRO1TEK Medical Trauma First Aid Bleeding Control Kit- 1+ Patient with SWAT Tourniquet - Vehicle Glove Compartment Kit.
Catalog Number
-
Brand Name
PRO1TEK Trauma First Aid Bleeding Control Kit - Vehicle Kit
Version/Model Number
B283CTKOST10
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
-
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
OVR
Product Code Name
Kit, First Aid, Talking
Public Device Record Key
ebb79b2a-ed72-4554-8c53-729f4d5b3df4
Public Version Date
April 01, 2019
Public Version Number
2
DI Record Publish Date
March 21, 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 | 29 |