SPIDERVIEW

GUDID 08031527015064

MICROPORT CRM SRL

Electrocardiographic lead set, reusable

• Primary Device ID: 08031527015064
• NIH Device Record Key: 9276b1ad-f253-40cc-821a-2d305c06ebd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIDERVIEW
• Version Model Number: XYZ-HR / 7E
• 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	08031527015064 [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

On-Brand Devices [SPIDERVIEW]

• 08031527016023: 7 leads
• 08031527015095: 3 Leads XYZ / 7E
• 08031527015088: 2 Leads / 5 E
• 08031527015071: 12 Leads / 10 E
• 08031527015064: XYZ-HR / 7E