BIOtherm™

GUDID 00613994009647

EXCHANGER 61399400964 12CA HT BIOTHERM

MEDTRONIC, INC.

Cardiopulmonary bypass system heat exchanger, reusable

• Primary Device ID: 00613994009647
• NIH Device Record Key: 6e66f29a-8b0c-4920-9099-f100e4a2fc3b
• Commercial Distribution Discontinuation: 2015-06-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIOtherm™
• Version Model Number: 61399400964
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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: true
• 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

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994009647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884560

FDA Product Code

• DTR: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-06-09

On-Brand Devices [BIOtherm™]

• 00613994009647: EXCHANGER 61399400964 12CA HT BIOTHERM
• 30613994009648: EXCHANGER 61399400964 1EA HT BIOTHERM