ECMOtherm- II™

GUDID 30613994008702

EXCHANGER 61399400870 1EA EMOTHRMII HT

MEDTRONIC, INC.

Cardiopulmonary bypass system heat exchanger, reusable

• Primary Device ID: 30613994008702
• NIH Device Record Key: d92646ba-f092-4b29-8a28-245f6279fec0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECMOtherm- II™
• Version Model Number: 61399400870
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30613994008702 [Primary]
GS1	50613994008706 [Package]; Package: PK [12 Units]; In Commercial Distribution

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 [ECMOtherm- II™]

• 00613994008701: EXCHANGER 61399400870 12CA EMOTRMII HT
• 30613994008702: EXCHANGER 61399400870 1EA EMOTHRMII HT