10Fore™ MAPTEN4

GUDID 20884450821309

Merit Medical Systems, Inc.

Haemostasis valve

• Primary Device ID: 20884450821309
• NIH Device Record Key: 3ebcb2de-68c9-40b5-bb8d-5a7371052ed4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10Fore™
• Version Model Number: Initial Release
• Catalog Number: MAPTEN4
• 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	00884450821305 [Primary]
GS1	10884450821302 [Package]; Contains: 00884450821305; Package: [25 Units]; In Commercial Distribution
GS1	20884450821309 [Package]; Contains: 10884450821302; 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: 2025-03-24
• Device Publish Date: 2025-03-15

On-Brand Devices [10Fore™]

• 10884450832506: Initial Release
• 20884450821309: Initial Release