Merit® Kit K14-00014

GUDID 10884450137427

Merit Medical Systems, Inc.

Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 10884450137427
• NIH Device Record Key: 89558e39-f305-44ee-aa2c-59928847eeb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merit® Kit
• Version Model Number: 00884450137420
• Catalog Number: K14-00014
• 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: 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450137420 [Primary]
GS1	10884450137427 [Package]; Contains: 00884450137420; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090148

FDA Product Code

• MSD: Catheter, hemodialysis, implanted

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: 2016-09-20

On-Brand Devices [Merit® Kit]

• 10884450328757: 00884450328750
• 10884450328627: 00884450328620
• 10884450328610: 00884450328613
• 10884450328603: 00884450328606
• 10884450322502: 00884450322505
• 10884450322496: 00884450322499
• 10884450322465: 00884450322468
• 10884450322458: 00884450322451
• 10884450322441: 00884450322444
• 10884450322434: 00884450322437
• 10884450322427: 00884450322420
• 20884450316263: 00884450316269
• 10884450292232: 00884450292235
• 20884450278226: 00884450278222
• 20884450276994: 00884450276990
• 20884450276987: 00884450276983
• 10884450273071: 00884450273074
• 10884450256418: 00884450256411
• 10884450256401: 00884450256404
• 10884450256395: 00884450256398
• 10884450256340: 00884450256343
• 10884450240684: 00884450240687
• 10884450137458: 00884450137451
• 10884450137441: 00884450137444
• 10884450137434: 00884450137437
• 10884450137427: 00884450137420
• 10884450137410: 00884450137413
• 10884450137403: 00884450137406
• 10884450478919: 00884450478912
• 10884450499716: 00884450499719
• 10884450611118: 00884450611111