CONNECTOR, Y 1/4" X 1/2" X 1/2" W/OUT LUER

Basic Information

• Brand Name: CONNECTOR, Y 1/4" X 1/2" X 1/2" W/OUT LUER
• Primary DI: B066341244NS1
• Version / Model: 341244NS
• Catalog Number: 341244NS
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2015-10-13
• Public Version: 3
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: deb0cc23-a570-480f-b9e6-01edc57b83fd

Device Description

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	870.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64696	Non-ISO80369-standardized small-bore multichannel connector, single-use	A small, non-powered, noninvasive, small-bore tubular connector with three or more connections (typically barbed, bayonet, conical, threaded and/or non-Luer-slip), none of which are designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), intended to connect three or more luminal devices (e.g., tubing, container) with each other during a medical procedure. It is typically T-, Y- or cross-shaped; it does not incorporate a filter, valve, clamp, tubing or puncturing component, and is not a dedicated gas-line connector. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B066341244NS3	HIBCC	PARTIAL CASE	1000	In Commercial Distribution
Primary	B066341244NS1	HIBCC
Unit of Use	B066341244NS0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K802542	000