Polyurethane Dual Lumen Occlusion Catheter 5F-2L-80

GUDID 00840663102280

Polyurethane Dual Lumen Occlusion Catheter, 5F, 80cm

LEMAITRE VASCULAR, INC.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00840663102280
• NIH Device Record Key: 38ccf9a2-00f9-4134-a652-d0af1db053ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polyurethane Dual Lumen Occlusion Catheter
• Version Model Number: 5F-2L-80
• Catalog Number: 5F-2L-80
• Company DUNS: 184805166
• Company Name: LEMAITRE VASCULAR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663102280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844918

FDA Product Code

• DQT: Occluder, Catheter Tip

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-06-30

On-Brand Devices [Polyurethane Dual Lumen Occlusion Catheter]

• 00840663102280: Polyurethane Dual Lumen Occlusion Catheter, 5F, 80cm
• 00840663102273: Polyurethane Dual Lumen Occlusion Catheter, 5F, 40cm
• 00840663102266: Polyurethane Dual Lumen Occlusion Catheter, 4F, 80cm
• 00840663102259: Polyurethane Dual Lumen Occlusion Catheter, 4F, 40cm