SYNESCOPE

GUDID 08031527015033

MICROPORT CRM SRL

Electrocardiographic long-term ambulatory recording analyser

• Primary Device ID: 08031527015033
• NIH Device Record Key: 0c9b7b57-656a-4dec-a818-5b166961cbe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNESCOPE
• Version Model Number: NETWORK LICENCE V3,10 USB
• 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	08031527015033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042002

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-20
• Device Publish Date: 2016-09-22

On-Brand Devices [SYNESCOPE]

• 08031527015040: UPGRADE TO SYNESCOPE V3.10 USB
• 08031527015033: NETWORK LICENCE V3,10 USB
• 08031527014289: SYNESCOPE V3.10 USB