SYNECOM

GUDID 08031527013435

MICROPORT CRM SRL

Electrocardiographic long-term ambulatory recording analyser

• Primary Device ID: 08031527013435
• NIH Device Record Key: 215e1f20-4128-4ada-8e13-e8c2b98e4937
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNECOM
• Version Model Number: V3.10
• 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	08031527013435 [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

Devices Manufactured by MICROPORT CRM SRL

• 08031527019611 - CPR4: 2023-07-04 Inductive Telemetry Head CPR4 USB
• 08031527019819 - Vega: 2023-07-04 VEGA Stylet Kit 45cm
• 08031527019826 - Vega: 2023-07-04 VEGA Stylet Kit 52cm
• 08031527019833 - Vega: 2023-07-04 VEGA Stylet Kit 58cm
• 08031527018997 - BlueSky: 2023-07-03 BlueSky DR Alizea 1600
• 08031527019000 - BlueSky: 2023-07-03 BlueSky SR Alizea 1300
• 08031527019017 - BlueSky: 2023-07-03 BlueSky DR Celea 1400
• 08031527019024 - BlueSky: 2023-07-03 BlueSky SR Celea 1100