BioMedicus®

GUDID 00613994608482

CANNULA CB98005-136 BIO-MED 21FR ART TAR

MEDTRONIC, INC.

Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral

• Primary Device ID: 00613994608482
• NIH Device Record Key: 18ee3d66-39bc-425a-86b3-d80cfa8eed33
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BioMedicus®
• Version Model Number: CB98005-136
• 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: true
• 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

• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994608482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924642

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 2018-12-11
• Device Publish Date: 2016-04-16

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