AccessGUDID - DEVICE: UltraSet CAPD Disposable Disconnect Y-Set (00085412030579)

GUDID

Device Identifier (DI) Information

Brand Name: UltraSet CAPD Disposable Disconnect Y-Set
Version or Model: 5C4366P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C4366P
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412030579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: The UltraSet products are single use devices that are intended for the drainage and infusion of peritoneal dialysis solution.

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":	No
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 [?]
K961825	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 035c8509-2ea0-4536-8fe5-93e1c82f3fe0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 07, 2015