Virtual Kit Number

GUDID 04033817901617

LivaNova Deutschland GmbH

Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor

• Primary Device ID: 04033817901617
• NIH Device Record Key: 59b5aa76-fa9d-410a-90df-9a7d5ee32ca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Virtual Kit Number
• Version Model Number: B-Capta FULL SYSTEM
• Company DUNS: 343225272
• Company Name: LivaNova Deutschland GmbH
• 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	04033817901617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202154

FDA Product Code

• DRY: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-24
• Device Publish Date: 2021-05-14

On-Brand Devices [Virtual Kit Number]

• 04033817903000: B-Capta VENOUS ONLY
• 04033817901617: B-Capta FULL SYSTEM