Duns Number:827067880
Device Description: PRO1TEK IFAK EMT CCR Leg Rig Bag with Hemostatic Dressing, CAT-T, Hyfin Chest Seal, Trauma PRO1TEK IFAK EMT CCR Leg Rig Bag with Hemostatic Dressing, CAT-T, Hyfin Chest Seal, Trauma Shears, NPA 28, Olaes Bandage and other Medical Supplies.
Catalog Number
-
Brand Name
PRO1TEK IFAK EMT CCR Leg RIG BAG
Version/Model Number
B283P1FDPD20
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
5db0607a-eb8f-4558-9313-d7741ff98d2f
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 |