Concierge®

GUDID 00884450036945

Merit Medical Systems, Inc.

Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use Angiographic catheter, single-use

• Primary Device ID: 00884450036945
• NIH Device Record Key: 0d9a96e3-373d-4b29-a2d7-e3a4489d94e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Concierge®
• Version Model Number: 00884450036945
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450036945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132409

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

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 [Concierge®]

• 00884450037782: 00884450037782
• 00884450037072: 00884450037072
• 00884450037058: 00884450037058
• 00884450036990: 00884450036990
• 00884450036976: 00884450036976
• 00884450036945: 00884450036945