Duns Number:042823948
Device Description: Subclavian Double Lumen Hemodialysis Set Polyurethane
Catalog Number
C-DDS-1201U-20
Brand Name
Cook
Version/Model Number
G05257
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 17, 2017
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MPB
Product Code Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Public Device Record Key
805a1923-78b5-4169-a103-f30ef4617945
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
October 24, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |