Occlutech ASD Occluder 37ASD19

GUDID 04260182521632

The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.

Occlutech GmbH

Cardiac defect occluder

• Primary Device ID: 04260182521632
• NIH Device Record Key: 0fecd3b3-2271-4bb4-a09a-337f386a131d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Occlutech ASD Occluder
• Version Model Number: 37ASD19
• Catalog Number: 37ASD19
• Company DUNS: 312548545
• Company Name: Occlutech GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter
• Outer Diameter: 19.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260182521632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200032

FDA Product Code

• OZG: Transcatheter Septal Occluder (Atrial)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-13
• Device Publish Date: 2024-03-05

On-Brand Devices [Occlutech ASD Occluder]

• 04260182521687: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521670: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521663: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521656: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521649: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521632: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521625: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521618: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521601: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521595: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521588: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521571: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521564: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521557: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 04260182521540: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device