XTRA

GUDID 04033817752219

LivaNova Deutschland GmbH

Red blood cell-recovery autotransfusion system

• Primary Device ID: 04033817752219
• NIH Device Record Key: fc90e971-534d-4a48-b6a2-3d998c439b5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XTRA
• Version Model Number: 100-120V
• 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	04033817752219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112245
• Premarket Notification: K131553

FDA Product Code

• CAC: APPARATUS, AUTOTRANSFUSION

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: 2021-01-08
• Device Publish Date: 2015-10-16

Devices Manufactured by LivaNova Deutschland GmbH

• 04033817901693 - Virtual Kit Number: 2024-07-31
• 04033817753070 - XVAC: 2024-05-07
• 04033817900023 - Venous Line Clamp: 2024-05-07
• 04033817900030 - Venous Line Clamp: 2024-05-07
• 04033817900047 - Venous Line Clamp: 2024-05-07
• 04033817900054 - Venous Line Clamp: 2024-05-07
• 04033817900061 - Venous Line Clamp: 2024-05-07
• 04033817900078 - Venous Line Clamp: 2024-05-07