FDA.reportPublic FDA data

NovaPort cannula

Primary DI
04260058550735
Brand
NovaPort cannula
Company
novalung GmbH
Model
NovaPort® one Vascular Access and Introducer Kit
Catalog number
8800078
Device description
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.
Published
2015-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112565000NOVAPORT ONE VASCULAR ACCESS CANNULANovalung GmbH2011-12-06DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260058550735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260058550735042600585507354260058550735

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, femoralA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49713127060info@novalung.com

Regulatory Flags#

DUNS number
331791694
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260058550728NovaPort cannulaNovaPort® one Vascular Access and Introducer Kit88000772015-09-30
04260058550742NovaPort cannulaNovaPort® one Vascular Access and Introducer Kit88000792015-09-30
04260058550759NovaPort cannulaNovaPort® one Vascular Access and Introducer Kit88000802015-09-30
04260058550711sLA Membrane LungNovalung® Surgical Lung Assist (sLA) MembraneLung 88000762015-09-30

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