AFFINITY™

GUDID 00643169745001

HANDCRANK HC150A

MEDTRONIC, INC.

Centrifugal circulatory assist pump, manual

• Primary Device ID: 00643169745001
• NIH Device Record Key: 25b61aaf-6def-4906-9806-cff1ba96d6be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFINITY™
• Version Model Number: HC150A
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169745001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100631

FDA Product Code

• DWA: Control, pump speed, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-04

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• 20643169858910: FILTER S4014 AFFINITYPEDIATRIC ART ST
• 20643169858842: FILTER 61399409434 AFFINITY 6PK ARFIL20M
• 20643169858835: FILTER 61399401124 AFFINITY 6PK ART 351
• 20643169767762: FILTER 61399401153 AFFINITY 6CA ART 352
• 20643169767748: FILTER 61399409503 AFFINITY ART 354 6PK
• 00643169745001: HANDCRANK HC150A
• 00763000219628: PROBE ATP210 AFFINITY TEMPERATURE
• 00643169272248: ADAPTER AP40AST AFFINITY CP WW
• 00763000301330: HANDCRANK HC150A PLX 31L
• 20763000134567: PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
• 20763000134550: PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
• 20763000134536: PUMP AP40 AFFINITY CP CENTRIFUGAL NC
• 00763000445744: FINAL PACK ATP210 TEMP PROBE GBL