CANNULAE, SAPHENOUS VEIN - A single lumen, tubular device designed to - NOVOSCI CORP.

Duns Number:938289980

Device Description: A single lumen, tubular device designed to deliver cardioplegic solution to the aortic roo A single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.

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More Product Details

Catalog Number

201006NS

Brand Name

CANNULAE, SAPHENOUS VEIN

Version/Model Number

201006NS

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)

Yes

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

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

6e88bbb5-94ec-4647-ac96-6a44c5fe5134

Public Version Date

September 23, 2022

Public Version Number

4

DI Record Publish Date

November 11, 2015

Additional Identifiers

Package DI Number

B066201006NS3

Quantity per Package

1000

Contains DI Package

B066201006NS1

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