Duns Number:088013219
Catalog Number
-
Brand Name
NXSTAGE CARTRIDGE EXPRESS
Version/Model Number
CAR-506
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"
Yes
For Single-Use
Yes
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
KDI
Product Code Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Public Device Record Key
abc64c4c-13c1-4b7f-906f-02c5dbcca54e
Public Version Date
November 08, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2015
Package DI Number
M535CAR5065
Quantity per Package
6
Contains DI Package
M535CAR5060
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 211 |