Medallion IZOff™ MIZ10

GUDID 20884450313972

Merit Medical Systems, Inc.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 20884450313972
• NIH Device Record Key: 27858b7d-4de7-4757-a351-1ac6ebb9c505
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medallion IZOff™
• Version Model Number: 00884450313978
• Catalog Number: MIZ10
• 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: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450313978 [Primary]
GS1	10884450313975 [Package]; Contains: 00884450313978; Package: [25 Units]; In Commercial Distribution
GS1	20884450313972 [Package]; Contains: 10884450313975; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171362

FDA Product Code

• FMF: Syringe, piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2017-12-18

Devices Manufactured by Merit Medical Systems, Inc.

• 00884450478196 - Merit Maestro®: 2024-04-25
• 10884450770655 - Performa®: 2024-04-25
• 00884450478264 - Merit Maestro®: 2024-04-24
• 00884450478288 - Merit Maestro®: 2024-04-24
• 10884450697259 - ProGuide™: 2024-04-24
• 10884450712303 - Impress®: 2024-04-24
• 00884450819111 - Merit Medical®: 2024-04-24
• 20884450709188 - Prelude®: 2024-04-24