CONN, Y 3/8" X 3/8" X 1/4" W/O LUER - A sterile plastic device designed to join two or - NOVOSCI CORP.

Duns Number:938289980

Device Description: A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass sy 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.

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More Product Details

Catalog Number

341332-000

Brand Name

CONN, Y 3/8" X 3/8" X 1/4" W/O LUER

Version/Model Number

341332-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KRI

Product Code Name

Accessory Equipment, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

326c9432-da54-4e9c-b6e0-2eb6548fbc9c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 13, 2015

Additional Identifiers

Package DI Number

B0663413320007

Quantity per Package

75

Contains DI Package

B0663413320000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PARTIAL CASE

"NOVOSCI CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50