Bio-Medicus®

GUDID 00613994622433

CANN CB96670-021 BIO-MEDICUS 21FR

MEDTRONIC, INC.

Cardiopulmonary bypass cannula, femoral

• Primary Device ID: 00613994622433
• NIH Device Record Key: 6c8508c6-cce2-4d06-a1cd-c58914d39919
• Commercial Distribution Discontinuation: 2017-08-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bio-Medicus®
• Version Model Number: CB96670-021
• 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

• Catheter Gauge: 21 French
• Catheter Gauge: 21 French
• Catheter Gauge: 21 French
• Catheter Gauge: 21 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994622433 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-24

On-Brand Devices [Bio-Medicus®]

• 00613994622549: CANN CB96345-023 BIO-MED 23FR
• 00613994622532: CANN CB96345-025 BIO-MED 25FR
• 00613994622525: CANN CB96345-027 BIO-MED 27FR
• 00613994622518: CANN CB96345-029 BIO-MED 29FR
• 00613994622501: CANN CB96570-015 BIO-MEDICUS 15FR
• 00613994622495: CANN CB96570-017 BIO-MEDICUS 17FR
• 00613994622488: CANN CB96570-019 BIO-MEDICUS 19FR
• 00613994622471: CANN CB96570-021 BIO-MEDICUS 21FR
• 00613994622464: CANN CB96670-015 BIO-MEDICUS 15FR
• 00613994622457: CANN CB96670-017 BIO-MEDICUS 17FR
• 00613994622440: CANN CB96670-019 BIO-MEDICUS 19FR EA
• 00613994622433: CANN CB96670-021 BIO-MEDICUS 21FR
• 00613994608581: CANNULA CB96535-015 BIO-MED 15FR ART KIT
• 00613994608574: CANNULA CB96535-017 BIO-MED 17FR ART KIT
• 00613994608567: CANNULA CB96535-019 BIO-MED 19FR ART KIT
• 00613994608550: CANNULA CB96535-021 BIO-MED 21FR ART KIT
• 00613994608543: CANNULA CB96540-023 BIO-MED 23FR ART KIT
• 00613994608536: CANNULA CB96605-015 BIO-MED 15FR VEN KIT
• 00613994608529: CANNULA CB96605-017 BIO-MED 17FR VEN KIT
• 00613994608512: CANNULA CB96605-019 BIO-MED 19FR VEN KIT
• 00613994608505: CANNULA CB96605-021 BIO-MED 21FR VEN KIT
• 00613994608499: CANNULA CB96605-023 BIO-MED 23FR VEN KIT
• 00613994608475: CANNULA CB98005-138 BIO-MED 23FR VEN KIT
• 00613994608468: CANNULA CB98005-139 BIO-MED 15FR ART KIT
• 00613994608451: CANNULA CB98005-140 BIO-MED 17FR VEN KIT
• 00613994608444: CANNULA CB98805-102 BIO-MED 14ART 0 HOLE
• 00613994608437: CANNULA CB98805-103 BIO-MED 12ART 0 HOLE
• 00613994608420: CANNULA CB98805-104 BIO-MED 10FR VEN KIT
• 00613994608413: CANNULA CB98805-105 BIO-MED 12FR VEN KIT
• 00613994608406: CANNULA CB98805-106 BIO-MED 14FR VEN KIT
• 00613994530813: CANNULA 96830-014 BIO-MED VEN 14F EA 17L
• 00613994530806: CANNULA 96830-012 BIO-MED VEN 12F EA 17L
• 00613994530790: CANNULA 96830-010 BIO-MED VEN 10F EA 17L
• 00613994530783: CANNULA 96830-008 BIO-MED VEN 8FR EA 17L
• 00613994530738: CANNULA 96820-014 BIO-MED ART 14F EA 17L
• 00613994530721: CANNULA 96820-012 BIO-MED ART 12F EA 17L
• 00613994530714: CANNULA 96820-010 BIO-MED ART 10F EA 17L
• 00613994530707: CANNULA 96820-008 BIO-MED ART 8FR EA 17L
• 00613994530677: CANNULA 98800-142 BIO-MED ART 14F EA 17L
• 00613994530660: CANNULA 98800-140 BIO-MED ART 12F EA 17L
• 00613994530653: CANNULA 98800-131 BIO-MED VEN 10F LL CON
• 00613994530646: CANNULA 98800-130 BIO-MED VEN 8F LL CONN
• 00613994530639: CANNULA 98800-128 BIO-MED ART 12F LL CON
• 00613994530622: CANNULA 98800-126 BIO-MED ART 8F LL CON
• 00613994530615: CANNULA 98800-115 BIO-MED VEN 14F LL CON
• 00613994530608: CANNULA 98800-110 BIO-MED ART 12F LL CON
• 00613994530592: CANNULA 98800-109 BIO-MED ART 10F LL CON
• 00613994530585: CANNULA 98800-108 BIO-MED ART 8F LL CON
• 00613994504845: CANNULA 96570-021 BIO-MEDICUS 21FR EA
• 00613994504838: CANNULA 96570-019 BIO-MEDICUS 19FR EA