SmartView monitor KC961

GUDID 08031527017877

MicroPort SmartView monitor V2+

MICROPORT CRM SRL

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• Primary Device ID: 08031527017877
• NIH Device Record Key: a4352d70-7785-47d6-8844-260df2f5323b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartView monitor
• Version Model Number: KC961
• Catalog Number: KC961
• Company DUNS: 438860859
• Company Name: MICROPORT CRM SRL
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08031527017877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980049

FDA Product Code

• OSR: Pacemaker/Icd/Crt Non-Implanted Components

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: 2021-09-30
• Device Publish Date: 2021-09-22

On-Brand Devices [SmartView monitor]

• 08031527013381: Wireless
• 08031527013374: Landline
• 08031527017877: MicroPort SmartView monitor V2+