ExpanSure Large Access Transseptal Dilator

GUDID 00685447004707

One transseptal dilator; one J-tip guidewire.

Baylis Médicale Cie Inc

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• Primary Device ID: 00685447004707
• NIH Device Record Key: ffb754e9-e713-4b10-91c8-aae95bf64e9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExpanSure Large Access Transseptal Dilator
• Version Model Number: ESD125-35-85-70-N
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie 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: true
• 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: 5144889801
• Email: info@baylismedical.com
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447004707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182064

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-22
• Device Publish Date: 2019-10-23

On-Brand Devices [ExpanSure Large Access Transseptal Dilator]

• 00685447004707: One transseptal dilator; one J-tip guidewire.
• 00685447004691: One transseptal dilator; one J-tip guidewire.