HeRO® HERO1003/A

GUDID 10884450282882

Merit Medical Systems, Inc.

Arteriovenous shunt

• Primary Device ID: 10884450282882
• NIH Device Record Key: fc0f7763-0dec-4a40-87d9-e1e386b04f10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeRO®
• Version Model Number: 00884450282885
• Catalog Number: HERO1003/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00884450282885 [Primary]
GS1	10884450282882 [Package]; Contains: 00884450282885; Package: [1 Units]; In Commercial Distribution
GS1	20884450282889 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124039

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [HeRO®]

• 10884450386528: 00884450386521
• 10884450386511: 00884450386514
• 10884450329556: 00884450329559
• 10884450320560: 00884450320563
• 10884450320546: 00884450320549
• 20884450310193: 00884450310199
• 20884450310179: 00884450310175
• 10884450310158: 00884450310151
• 10884450309244: 00884450309247
• 10884450309237: 00884450309230
• 10884450288976: 00884450288979
• 10884450288969: 00884450288962
• 10884450282905: 00884450282908
• 10884450282882: 00884450282885
• 20884450282865: 00884450282861
• 20884450282841: 00884450282847
• 10884450385682: 00884450385685
• 20884450385672: 00884450385678
• 10884450415273: 00884450415276
• 10884450554392: 00884450554395
• 10884450564315: 00884450564318
• 00884450564301: 00884450564301
• 00884450563922: 00884450563922
• 00884450563915: 00884450563915
• 00884450564363: 00884450564363
• 10884450564322: 00884450564325
• 10884450563905: 00884450563908