CUSTODIA

GUDID 08031527015132

SORIN GROUP ITALIA SRL

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder 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

• 38033178018648 - Suction tip: 2024-04-12
• 38033178018655 - Suction tip: 2024-04-12
• 38033178018662 - Suction tip: 2024-04-12
• 38033178018679 - Suction tip: 2024-04-12
• 38033178018709 - Suction tip: 2024-04-12
• 38033178018716 - Suction tip: 2024-04-12
• 38033178018723 - Suction tip: 2024-04-12
• 38033178018730 - Suction tip: 2024-04-12