AccessGUDID - DEVICE: CYCLER DRAINAGE BAG (07332414207939)

GUDID

Device Identifier (DI) Information

Brand Name: CYCLER DRAINAGE BAG
Version or Model: 5C4145NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C4145NS
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 07332414207939
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005083209 *Terms of Use
Previous DI: 00085412722894

Device Description: The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Vantive Automated Peritoneal Dialysis (APD) Cycler Tubing Sets.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35000	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDJ	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214016	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room Temperature

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 15 Liter

Device Record Status

Public Device Record Key: cefcdc82-3f2e-4192-acb5-7d73e5a57091
Public Version Date: March 28, 2025
Public Version Number: 1
DI Record Publish Date: March 20, 2025