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 with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
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
K152938
Product Code
KDI
Product Code Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Public Device Record Key
f20b6d6b-36f8-42ae-b9bb-fb59a9a0bd31
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 12, 2016
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 |