Duns Number:827067880
Device Description: PRO1TEK IFAK EMT BAG with Hemostatic Dressing, Cat Tourniquet, Hyfin Chest Seal, NPA 28, O PRO1TEK IFAK EMT BAG with Hemostatic Dressing, Cat Tourniquet, Hyfin Chest Seal, NPA 28, Olaes Bandage, Trauma Shears and other basic Medical supplies
Catalog Number
-
Brand Name
PRO1TEK IFAK EMT BAG
Version/Model Number
B283P1FDPD
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)
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
621ae752-b46a-4c4a-a044-a3ad87a59291
Public Version Date
June 04, 2021
Public Version Number
1
DI Record Publish Date
May 27, 2021
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 |