IDEAL™ MAXPAC® TOTAL SYSTEM

GUDID 00643169503557

MAXPAC TS1628R1 HY7Z58R5

MEDTRONIC, INC.

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• Primary Device ID: 00643169503557
• NIH Device Record Key: 12594154-c407-491a-a35e-ecac2eadeed6
• Commercial Distribution Discontinuation: 2015-01-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IDEAL™ MAXPAC® TOTAL SYSTEM
• Version Model Number: TS1628R1
• 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: true
• Device Combination Product: false
• 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: 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
• 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
• 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 *Do not store at temperatures above 40 C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at temperatures above 40 C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169503557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973011

FDA Product Code

• KFM: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

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: 2014-09-23

On-Brand Devices [IDEAL™ MAXPAC® TOTAL SYSTEM]

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• 00643169503557: MAXPAC TS1628R1 HY7Z58R5
• 00643169408265: MAXPAC TS1477R12 CB4S43R9
• 00643169225435: MAX PAC TS1567R1 6W38R3