Duns Number:827067880
Device Description: PRO1TEK Medical Trauma First Aid Advanced Bleeding Kit-1+ Patient with Hemostatic Dressing PRO1TEK Medical Trauma First Aid Advanced Bleeding Kit-1+ Patient with Hemostatic Dressing and other Bleeding Control Aids
Catalog Number
-
Brand Name
PRO1TEK Trauma First Aid Advanced IFAK Kit
Version/Model Number
B283EIF1BBP0
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
OVR
Product Code Name
Kit, First Aid, Talking
Public Device Record Key
24a5c701-9ff0-4fcc-b67d-faebe9658820
Public Version Date
May 11, 2022
Public Version Number
1
DI Record Publish Date
May 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 | 29 |