Peritoneal Dialysis CS-352/A

GUDID 10884450277468

Merit Medical Systems, Inc.

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• Primary Device ID: 10884450277468
• NIH Device Record Key: 0a0a2379-9fb9-42ce-8037-20ddb9bd8199
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peritoneal Dialysis
• Version Model Number: 00884450277461
• Catalog Number: CS-352/A
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450277461 [Primary]
GS1	10884450277468 [Package]; Contains: 00884450277461; Package: [56 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823296

FDA Product Code

• FKX: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Peritoneal Dialysis]

• 00884450277478: 00884450277478
• 10884450277468: 00884450277461
• 00884450277454: 00884450277454
• 10884450462789: 00884450462782
• 10884450462772: 00884450462775
• 10884450462758: 00884450462751