VersaCross Connect™ VXAK0057

GUDID 00685447020103

Access Solution for CARTO VIZIGO™ Sheath

Baylis Médicale Cie Inc

Cardiac transseptal access set

• Primary Device ID: 00685447020103
• NIH Device Record Key: 4aba396d-6ad8-4294-b38c-a800f94735ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross Connect™
• Version Model Number: VXAK0057
• Catalog Number: VXAK0057
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447020103 [Primary]

FDA Product Code

• OFK: Percutaneous atrial catheter kit

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: 2024-08-28
• Device Publish Date: 2024-08-20

On-Brand Devices [VersaCross Connect™]

• 00685447020103: Access Solution for CARTO VIZIGO™ Sheath
• 00685447020080: Access Solution for CARTO VIZIGO™ Sheath