TandemHeart

GUDID 00814112020067

21 Fr x 62 cm venous cannula with dilator and introducer

CARDIACASSIST, INC.

Circulatory assist transseptal cannula

• Primary Device ID: 00814112020067
• NIH Device Record Key: 3a452c32-a6c5-4660-a2fd-d75bd83d0e5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TandemHeart
• Version Model Number: 5140-6221
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx

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
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020067 [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: 2015-10-10

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