DEVICE: Cycler Drainage Bag (00085412007410)

Device Identifier (DI) Information

Cycler Drainage Bag
5C4145P
In Commercial Distribution
5C4145P
BAXTER INTERNATIONAL INC.
00085412007410
GS1

2
005146311 *Terms of Use
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.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Peritoneal dialysis system tubing set A sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KDJ SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K791899 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Total Volume: 15 Liter
CLOSE

Device Record Status

6f94c06a-3081-4e4c-8daf-56c3f542f63e
July 06, 2018
3
September 24, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50085412007415 30 00085412007410 In Commercial Distribution CASE
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 90085412007413 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
CLOSE