Duns Number:005146311
Device Description: This product is to be used with Baxter APD Sets with Cassette. Baxter Manifold Sets and Ex This product is to be used with Baxter APD Sets with Cassette. Baxter Manifold Sets and Extension Sets may also be used. Consult instructions for use.
Catalog Number
5C4145P
Brand Name
Cycler Drainage Bag
Version/Model Number
5C4145P
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
K791899,K791899,K791899
Product Code
KDJ
Product Code Name
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Public Device Record Key
6f94c06a-3081-4e4c-8daf-56c3f542f63e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
50085412007415
Quantity per Package
30
Contains DI Package
00085412007410
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 |