B-Capta

GUDID 04033817902836

LivaNova Deutschland GmbH

Extracorporeal blood gas/pH monitor

• Primary Device ID: 04033817902836
• NIH Device Record Key: ad38cd24-55b9-4f99-a58b-6265c15bf55b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-Capta
• Version Model Number: Sensor Module
• 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: true
• 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	04033817902836 [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 [B-Capta]

• 04033817902836: Sensor Module
• 04033817901631: Arterial Sensor
• 04033817901624: Venous Sensor