Duns Number:796083392
Catalog Number
-
Brand Name
Dialysate Port Caps 1.5" Bulk
Version/Model Number
7000-0004
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
9ebb93b4-b63d-4c5f-a945-199074b9ad8b
Public Version Date
September 03, 2019
Public Version Number
1
DI Record Publish Date
August 26, 2019
Package DI Number
10858293006226
Quantity per Package
1000
Contains DI Package
00858293006229
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 |