Duns Number:690542378
Device Description: The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physic The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients only with acute or chronic renal failure. The DBB-06 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified, trained operator only.
Catalog Number
-
Brand Name
HEMODIALYSIS DELIVERY SYSTEM
Version/Model Number
DBB-06
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)
Yes
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
K091978
Product Code
KDI
Product Code Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Public Device Record Key
d7ba96c7-1c7b-4e9b-8d9e-68c85b64be93
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |