Duns Number:827067880
Device Description: PRO1TEK 2+ Patient Specialty IFAK Kit - Contains Bleeding Control tools with the addition PRO1TEK 2+ Patient Specialty IFAK Kit - Contains Bleeding Control tools with the addition of a Hemostatic Dressing and other Trauma Kit and First-Aid Equipment.
Catalog Number
-
Brand Name
PRO1TEK 2+Patient Specialty IFAK Kit
Version/Model Number
B283PTOXFIFAK010
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
LRR
Product Code Name
First Aid Kit With Drug
Public Device Record Key
4184480b-57a2-4415-ade4-8b7b9764ec1d
Public Version Date
May 19, 2022
Public Version Number
2
DI Record Publish Date
April 27, 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 |