TMC 38

GUDID 20681490009823

CONN TMC38 BIOTREND 3/8 CUVETTE 12PK

MEDTRONIC, INC.

Cardiopulmonary bypass system blood gas sensor

• Primary Device ID: 20681490009823
• NIH Device Record Key: 3ced3cbe-b81b-4fde-a931-f3a158c4ab1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMC 38
• Version Model Number: TMC38
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490009829 [Primary]
GS1	20681490009823 [Package]; Contains: 00681490009829; Package: PK [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012743

FDA Product Code

• DRY: MONITOR, BLOOD-GAS, ON-LINE, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-17

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