DEVICE: NovaPort cannula (04260058550735)

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Device Identifier (DI) Information

NovaPort cannula
NovaPort® one Vascular Access and Introducer Kit
8800078
novalung GmbH
04260058550735
GS1
1
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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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cardiopulmonary bypass cannula, femoral A sterile, rigid or semi-rigid tube designed to be inserted into a femoral artery or vein during cardiopulmonary bypass procedures. It is typically a 9 to 24 Fr tube with an end hole (some may include side holes); it is short enough to keep the distal tip inside the femoral vessel. The tube is used in set-ups/systems intended to divert the patient's blood to and from external tubing and an arterial pump, bypassing the heart and lungs completely. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 15 French
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Device Status

In Commercial Distribution
September 30, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+49713127060
info@novalung.com
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