Reducing Connector Y 1/2 x 3/8 x 3/8 - 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

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More Product Details

Catalog Number

C440S

Brand Name

Reducing Connector Y 1/2 x 3/8 x 3/8

Version/Model Number

C440S

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

KOC

Product Code Name

Accessories, Blood Circuit, Hemodialysis

Device Record Status

Public Device Record Key

5ce93b0b-2e20-448e-922e-4ce6dc64fe07

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

B066C440S6

Quantity per Package

240

Contains DI Package

B066C440S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

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