Distal Perfusion Catheter 2105-15

GUDID 00840663101610

Distal Perfusion Catheter, 12F

LEMAITRE VASCULAR, INC.

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00840663101610
• NIH Device Record Key: cba228b9-27ba-4bf9-bf6a-65e45bb045d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Perfusion Catheter
• Version Model Number: 2105-15
• Catalog Number: 2105-15
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663101610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032041

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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

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• 00840663108787 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 2.5cm x 15cm
• 00840663108794 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 5cm x 10cm
• 00840663108800 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 12cm x 25cm
• 00840663108824 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 5cm x 10cm, eIFU
• 00840663108831 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 2.5cm x 15cm, eIFU
• 00840663108916 - YES Tape: 2021-06-28 YES Tape