Duns Number:005146311
Device Description: This set is intended for use with a Baxter transfer set for peritoneal dialysis patients r This set is intended for use with a Baxter transfer set for peritoneal dialysis patients requiring a sterile container for drainage. (i.e. CCPD patients doing a daytime exchange or CAPD patients who have disconnected between exchanges).
Catalog Number
5C4462
Brand Name
Empty Sterile Container
Version/Model Number
5C4462
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
K833065,K833065
Product Code
FKX
Product Code Name
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Public Device Record Key
f8ceba36-7420-40d7-acc6-0c752d0a31b1
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
50085412007675
Quantity per Package
48
Contains DI Package
00085412007670
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 |