CUSTODIA

GUDID 08031527015132

SORIN GROUP ITALIA SRL

Electrocardiographic ambulatory recorder

• Primary Device ID: 08031527015132
• NIH Device Record Key: d2f7e297-afb5-459d-ba8a-a54081f95ada
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUSTODIA
• Version Model Number: SPIDERVIEW
• Company DUNS: 434932033
• Company Name: SORIN GROUP ITALIA 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	08031527015132 [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: 2019-11-08
• Device Publish Date: 2016-09-22

Devices Manufactured by SORIN GROUP ITALIA SRL

• 18033178113707 - XTRA: 2024-12-30
• 18033178113714 - XTRA: 2024-12-30
• 38033178113725 - XTRA: 2024-12-30
• 38033178113732 - XTRA: 2024-12-30
• 38033178113749 - XTRA: 2024-12-30
• 38033178113756 - XTRA: 2024-12-30
• 38033178113763 - XTRA: 2024-12-30
• 38033178113923 - XTRA: 2024-12-30