Duns Number:796083392
Catalog Number
-
Brand Name
Blood Port Caps Twist Lock ISO
Version/Model Number
7000-1003
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FJI
Product Code Name
Dialyzer, Capillary, Hollow Fiber
Public Device Record Key
30dc524c-f111-4998-b490-b00fefc8f980
Public Version Date
September 04, 2019
Public Version Number
1
DI Record Publish Date
August 27, 2019
Package DI Number
10858293006295
Quantity per Package
100
Contains DI Package
00858293006298
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 30 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |