Duns Number:626802540
Device Description: Bleeding Control Kit, custom, red case, PBCK1
Catalog Number
3332030
Brand Name
Bleeding Control Kit
Version/Model Number
Bleeding Control Kit Custom
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
9ae9879a-870a-4082-aa1a-e2f57ff71c7c
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
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 | 138 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |