NovaPort cannula - The NovaPort® one cannulas are thin-walled, - novalung GmbH

Duns Number:331791694

Device Description: The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a co The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where the cannulas can be clamped. The NovaPort® one cannulas are inserted percutaneously (Seldinger technique) into vessels. All necessary accessories are delivered with the product.

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More Product Details

Catalog Number

8800080

Brand Name

NovaPort cannula

Version/Model Number

NovaPort® one Vascular Access and Introducer Kit

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

Issuing Agency

In GS1

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

935de86c-c12d-429d-881b-d2a7b877812c

Public Version Date

December 17, 2020

Public Version Number

4

DI Record Publish Date

September 30, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVALUNG GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5