Custom Perfusion System

GUDID 00643169333642

CUSTOM PACK TL7M38R7 ADULT PK

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00643169333642
• NIH Device Record Key: fd2fee84-f44d-43b2-a8c6-373ef392ccbe
• Commercial Distribution Discontinuation: 2015-09-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Custom Perfusion System
• Version Model Number: TL7M38R7
• 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: true
• 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
• 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
• 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.
• 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.
• 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	00643169333642 [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 [Custom Perfusion System]

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• 00613994910233: CUSTOM PACK 6W81R1 PEDIATRIC
• 00613994909442: CUSTOM PACK HY2280R16 MASTER M
• 00613994909084: CUSTOM PACK CB5175R13 PEDIATRI
• 00613994909077: CUSTOM PACK CB5174R11 INFANT
• 00613994907530: CUSTOM PACK CB6X08R MGHLH
• 00613994877246: CUSTOM PACK CB6U76R1 VA ADULT
• 00613994872456: CUSTOM PACK 6T01R2 ADULT E
• 00613994871367: CUSTOM PACK CB4S43R9 AFFINITY
• 00613994859976: CUSTOM PACK HY1C73R22 ARNOTS
• 00613994853011: CUSTOM PACK TL5V20R4 LA CVT
• 00613994852045: CUSTOM PACK TL6U52R BIO PUMP
• 00613994837790: CUSTOM PACK CB6S67R L H BYPASS
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• 00613994806444: CUSTOM PACK TL6S28R2 FEMFEM SP
• 00613994803948: CUSTOM PACK CB6Q04R SUPPORT
• 00613994803191: CUSTOM PACK CB5B43R5 3/8 PUMP
• 00613994798923: CUSTOM PACK HY2Q32R3 P/T PGIA
• 00613994795038: CUSTOM PACK HY2Q31R3 P/T CPGIA
• 00613994778710: CUSTOM PACK HY5333R16 1/4 CPS
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• 00613994774132: CUSTOM PACK CB6Q97R2 V SUPPRT
• 00613994773623: CUSTOM PACK CB4W67R10 ADULT E
• 00613994773098: CUSTOM PACK CB4M26R2 L SUPPORT
• 00613994772879: CUSTOM PACK HY1W12R19 CV
• 00613994758040: CUSTOM PACK CB3U53R10 WB TABLE
• 00613994757272: CUSTOM PACK CB6Q78R2 SUPP BP80
• 00613994757111: CUSTOM PACK 2D64R16 UNIV PA
• 00613994756978: CUSTOM PACK HY6Q18R1 OPEN SYS
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• 00613994753489: CUSTOM PACK HY3L72R3 L PACK
• 00613994753472: CUSTOM PACK CB4907R13 L/T SPRT
• 00613994752376: CUSTOM PACK HY5D70R3 VACUUM PK
• 00613994751386: CUSTOM PACK 6Q49R1 UNCOATED
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