SPIDERVIEW / SPIDERFLASH

GUDID 08031527015057

MICROPORT CRM SRL

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 08031527015057
• NIH Device Record Key: 85a5c7cf-beb1-4c5d-a946-e74d386c46ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIDERVIEW / SPIDERFLASH
• Version Model Number: 2 Leads / 3E
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08031527015057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032466

FDA Product Code

• MWJ: ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)

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