DiamondTOUCH™ IN9135

GUDID 20884450264908

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 20884450264908
• NIH Device Record Key: dd66955f-16f5-46ed-a4cf-fc479b726b53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiamondTOUCH™
• Version Model Number: 00884450264904
• Catalog Number: IN9135
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450264904 [Primary]
GS1	10884450264901 [Package]; Contains: 00884450264904; Package: [5 Units]; In Commercial Distribution
GS1	20884450264908 [Package]; Contains: 10884450264901; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160107

FDA Product Code

• DXT: INJECTOR AND SYRINGE, ANGIOGRAPHIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-09-26

On-Brand Devices [DiamondTOUCH™]

• 10884450324810: 00884450324813
• 20884450324800: 00884450324806
• 10884450324780: 00884450324783
• 20884450264908: 00884450264904
• 20884450413467: 00884450413463
• 10884450409654: 00884450409657
• 10884450409647: 00884450409640
• 10884450021252: B
• 10884450021269: B
• 10884450021344: A