LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER

Basic Information

• Brand Name: LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER
• Primary DI: 07332414207946
• Version / Model: 5C4129
• Catalog Number: 5C4129
• Company Name: Vantive US Healthcare LLC
• Labeler DUNS: 119181963
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-23
• Public Version: 1
• Public Version Date: 2025-10-01
• Public Version Status: New
• Public Device Record Key: 011c2f43-73af-4f39-8e38-97f42cd9272c

Device Description

This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector.

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: Yes
• 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: Yes
• 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
35944	Peritoneal dialysis catheter adaptor, single-use	A connecting device, often in two pieces, intended to be used to join a peritoneal dialysis catheter to the dialysate line during treatment. It is typically made of plastic or metal and may be used when the devices to be connected are from different manufacturers and not compatible, enabling them to mate, and/or within a mechanical connection system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27332414207940	GS1	PACK	5	In Commercial Distribution
Primary	07332414207946	GS1
Package	57332414207941	GS1	CASE	39	In Commercial Distribution
Previous	00085412007403	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152675	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature.