CONN, WYE 1/4" X 3/8" X 3/8" W/LL

Basic Information

• Brand Name: CONN, WYE 1/4" X 3/8" X 3/8" W/LL
• Primary DI: B066C475S0
• Version / Model: C475S
• Catalog Number: C475S
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-09
• Public Version: 3
• Public Version Date: 2023-07-10
• Public Version Status: Update
• Public Device Record Key: 1d26f6bb-a70d-4515-8e86-158d2591bc3d
• Distribution End Date: 2023-07-07

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): No
• 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: Yes
• 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
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	876.5820	2

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	B066C475S6	HIBCC	CASE	240	Not in Commercial Distribution	2023-07-07
Primary	B066C475S0	HIBCC
Package	B066C475S5	HIBCC	PARTIAL CASE	120	Not in Commercial Distribution	2023-07-07
Package	B066C475S4	HIBCC	PARTIAL CASE	96	Not in Commercial Distribution	2023-07-07
Package	B066C475S3	HIBCC	INNER CARTON	12	Not in Commercial Distribution	2023-07-07

Customer Contacts

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