Nit-Occlud PDA 145076V2

GUDID 4042301160003

Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.

pfm medical ag

Cardiac occluder

• Primary Device ID: 4042301160003
• NIH Device Record Key: c39c6016-e163-4a60-bc71-3b0bf0a860be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nit-Occlud PDA
• Version Model Number: 145076V2
• Catalog Number: 145076V2
• Company DUNS: 316661214
• Company Name: pfm medical ag
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04042301159991 [Primary]
GS1	4042301160003 [Package]; Contains: 04042301159991; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120009

FDA Product Code

• MAE: Occluder, Patent Ductus, Arteriosus

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-08-06

On-Brand Devices [Nit-Occlud PDA]

• 4042301160041: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with
• 4042301160027: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with
• 4042301160003: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with
• 4042301159984: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with
• 4042301159960: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with
• 04042301159939: Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with