Duns Number:005146311
Device Description: This device is indicated for use in the treatment of patients with renal failure to provid This device is indicated for use in the treatment of patients with renal failure to provide extended length to the drain line of the Baxter Automated PD Disposable Sets.
Catalog Number
5C4464P
Brand Name
Extension Set
Version/Model Number
5C4464P
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K833065,K833065
Product Code
FKX
Product Code Name
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Public Device Record Key
c88c345a-da0a-46fb-915c-99a7586418fe
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
50085412030550
Quantity per Package
30
Contains DI Package
00085412030555
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |