10Fore™ MAPTEN42

GUDID 10884450832506

Merit Medical Systems, Inc.

Haemostasis valve

• Primary Device ID: 10884450832506
• NIH Device Record Key: aeedee6c-a62b-49bc-86c4-a999bd5f77a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10Fore™
• Version Model Number: Initial Release
• Catalog Number: MAPTEN42
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450832509 [Primary]
GS1	10884450832506 [Package]; Contains: 00884450832509; Package: [25 Units]; In Commercial Distribution
GS1	20884450832503 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• DTL: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

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: 2025-03-03
• Device Publish Date: 2025-02-22

Devices Manufactured by Merit Medical Systems, Inc.

• 10884450644802 - SureCross: 2025-03-03
• 10884450755645 - Impress®: 2025-03-03
• 10884450787899 - Impress®: 2025-03-03
• 10884450788421 - Impress®: 2025-03-03
• 00884450807750 - Merit Medical®: 2025-03-03
• 00884450812594 - Merit Medical®: 2025-03-03
• 20884450818101 - MBA™: 2025-03-03
• 10884450832506 - 10Fore™: 2025-03-03
• 10884450832506 - 10Fore™: 2025-03-03