TSX™ M004TSXSHEATH300

GUDID 10884450466626

Merit Medical Systems, Inc.

Cardiac transseptal access set

• Primary Device ID: 10884450466626
• NIH Device Record Key: 14b8c4b6-9299-43f1-a128-73a17516d2ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSX™
• Version Model Number: 00884450466629
• Catalog Number: M004TSXSHEATH300
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450466629 [Primary]
GS1	10884450466626 [Package]; Contains: 00884450466629; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132720

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2021-06-07
• Device Publish Date: 2021-05-28

On-Brand Devices [TSX™]

• 10884450466626: 00884450466629
• 00884450466698: 00884450466698
• 10884450466701: 00884450466704
• 10884450466688: 00884450466681
• 10884450466671: 00884450466674
• 10884450466664: 00884450466667
• 10884450466657: 00884450466650
• 10884450466633: 00884450466636
• 10884450466619: 00884450466612
• 10884450466602: 00884450466605