Impress® THER510038JL45

GUDID 00884450168264

Merit Medical Systems, Inc.

Angiographic catheter, single-use

• Primary Device ID: 00884450168264
• NIH Device Record Key: 5cd0d65d-64f7-40b0-933f-6678d307e977
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impress®
• Version Model Number: 00884450168264
• Catalog Number: THER510038JL45
• 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: true
• Expiration Date: false
• 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	00884450168264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943739

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-29
• Device Publish Date: 2019-10-21

On-Brand Devices [Impress®]

• 10884450388201: 00884450388204
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• 10884450324728: 00884450324721
• 10884450324704: 00884450324707
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• 10884450295912: 00884450295915
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• 10884450277390: 00884450277393
• 10884450274719: 00884450274712