Impress® 512538STS-H

GUDID 10884450120351

Merit Medical Systems, Inc.

Angiographic catheter, single-use

• Primary Device ID: 10884450120351
• NIH Device Record Key: 58dd1885-c289-4d17-82d7-9a671455bfe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impress®
• Version Model Number: 00884450120354
• Catalog Number: 512538STS-H
• 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	00884450120354 [Primary]
GS1	10884450120351 [Package]; Contains: 00884450120354; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093004

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

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 [Impress®]

• 10884450388201: 00884450388204
• 10884450382483: 00884450382486
• 10884450324728: 00884450324721
• 10884450324704: 00884450324707
• 10884450315641: 00884450315644
• 10884450315627: 00884450315620
• 10884450313951: 00884450313954
• 10884450306519: 00884450306512
• 10884450306427: 00884450306420
• 10884450300012: 00884450300015
• 10884450295929: 00884450295922
• 10884450295912: 00884450295915
• 10884450295905: 00884450295908
• 10884450295899: 00884450295892
• 10884450295882: 00884450295885
• 10884450294564: 00884450294567
• 10884450294236: 00884450294239
• 10884450292294: 00884450292297
• 10884450287238: 00884450287231
• 10884450287160: 00884450287163
• 10884450287153: 00884450287156
• 10884450287078: 00884450287071
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• 10884450286132: 00884450286135
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• 10884450283254: 00884450283257
• 10884450283247: 00884450283240
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• 10884450283148: 00884450283141
• 10884450277390: 00884450277393
• 10884450274719: 00884450274712