TandemHeart

GUDID 00814112020395

TandemHeart blood pump kit with 72cm venous and 15Fr arterial cannulae

CARDIACASSIST, INC.

Circulatory assist transseptal cannula Circulatory assist transseptal cannula Circulatory assist transseptal cannula Circulatory assist transseptal cannula Circulatory assist transseptal cannula

• Primary Device ID: 00814112020395
• NIH Device Record Key: 5b064cb9-781a-41c6-979e-a8b1d58d02a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TandemHeart
• Version Model Number: 5710-7215
• Company DUNS: 948683941
• Company Name: CARDIACASSIST, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052570

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: 2018-10-03
• Device Publish Date: 2016-07-25

On-Brand Devices [TandemHeart]

• 00814112020395: TandemHeart blood pump kit with 72cm venous and 15Fr arterial cannulae
• 00814112020388: TandemHeart blood pump kit with 72cm venous and 17Fr arterial cannulae
• 00814112020371: TandemHeart blood pump kit with 62cm venous and 15Fr arterial cannulae
• 00814112020364: TandemHeart blood pump kit with 62cm venous and 17Fr arterial cannulae
• 00814112020265: TandemHeart Holster, Blood Pump and Oxygenator Securement Accessory
• 00814112020180: TandemHeart wrap, blood pump securement accessory
• 00814112020111: 15 Fr x 17 cm femoral arterial cannula with 10 Fr introducer
• 00814112020104: 17 Fr x 17 cm femoral arterial cannula with 12 Fr Introducer
• 00814112020098: 21 Fr x 72 cm venous cannula with dilator and introducer
• 00814112020067: 21 Fr x 62 cm venous cannula with dilator and introducer
• 00814112020050: TandemHeart blood pump kit with accessories
• 00814112020043: TandemHeart blood pump
• 00814112020036: TandemHeart blood pump kit with venous cannula
• 00814112020029: Infusion tubing (5 pack)
• 00814112020012: TandemHeart holster, blood pump securement accessory
• 00814112020005: Infusion tubing