AccessGUDID - DEVICE: CONNECTOR, Y 1/4" X 1/4" X 3/8" W/LUER (B066342223NS1)

GUDID

Device Identifier (DI) Information

Brand Name: CONNECTOR, Y 1/4" X 1/4" X 3/8" W/LUER
Version or Model: 342223NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 342223NS
Company Name: NOVOSCI CORP.

Primary DI Number: B066342223NS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

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

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRI	Accessory Equipment, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K802542	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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: 744f2152-1539-4916-bf10-af7f1762df15
Public Version Date: July 14, 2023
Public Version Number: 3
DI Record Publish Date: October 13, 2015