UltraSet CAPD Disposable Disconnect Y-Set

Basic Information

• Brand Name: UltraSet CAPD Disposable Disconnect Y-Set
• Primary DI: 00085412030579
• Version / Model: 5C4366P
• Catalog Number: 5C4366P
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 005146311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2015-10-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 035c8509-2ea0-4536-8fe5-93e1c82f3fe0

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDJ	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412030574	GS1	CASE	60	In Commercial Distribution
Primary	00085412030579	GS1
Unit of Use	90085412030572	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K961825	000