Affinity™

GUDID 00643169272248

ADAPTER AP40AST AFFINITY CP WW

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 00643169272248
• NIH Device Record Key: f8a51b6b-7ce5-4404-9da4-bf975bf40b7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity™
• Version Model Number: AP40AST
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing the adapter in direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extremes of temperature and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106.3 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing the adapter in direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extremes of temperature and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106.3 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing the adapter in direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extremes of temperature and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106.3 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing the adapter in direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169272248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132712

FDA Product Code

• KFM: Pump, blood, cardiopulmonary bypass, non-roller type

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-17
• Device Publish Date: 2019-06-09

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