Duns Number:005146311
Device Description: This Automated PD Set is compatible with Baxter Automated PD systems, Baxter PD Transfer S This Automated PD Set is compatible with Baxter Automated PD systems, Baxter PD Transfer Sets and Effluent Sample Bag. Use of the Clamp for Outlet Port is recommended. Low Recirculation Volume APD Set with Cassette (4-Prong Spike)
Catalog Number
5C8302C
Brand Name
LOW RECIRCULATION VOLUME APD SET
Version/Model Number
5C8302C
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"
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
K012988,K012988
Product Code
FKX
Product Code Name
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Public Device Record Key
a9bc34cc-81e0-45aa-93e8-abe478216955
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
50085412087400
Quantity per Package
30
Contains DI Package
00085412087405
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 |