Duns Number:827067880
Device Description: PRO1TEK 2+ Patient IFAK Kit with Wound Spray, Bleeding Control tools with Hemostatic Dress PRO1TEK 2+ Patient IFAK Kit with Wound Spray, Bleeding Control tools with Hemostatic Dressing and other Trauma Kit First-Aid Equipment.
Catalog Number
-
Brand Name
PRO1TEK 2+ Patient IFAK Kit
Version/Model Number
B283E1BB0
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
469f4913-10ed-4f03-bf21-249432df595d
Public Version Date
March 31, 2022
Public Version Number
1
DI Record Publish Date
March 23, 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 |