Intersept® Custom Tubing Pack

GUDID 00613994675712

ECMO PACK 2K88R1 PEDIATRIC

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00613994675712
• NIH Device Record Key: 14782fbb-2273-4fbb-a792-1855df0b4551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intersept® Custom Tubing Pack
• Version Model Number: 2K88R1
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994675712 [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 [Intersept® Custom Tubing Pack]

• 00613994951816: CUSTOM PACK 5347R7 MEMB W/BP80
• 00613994911773: CUSTOM PACK 5R69R4 PUMP / TBL
• 00613994910417: CUSTOM PACK 0N41R14 CROW H-L
• 00613994899798: CUSTOM PACK 2X16R4 VENUS
• 00613994896513: CUSTOM PACK 5J00R2 L SUPPORT
• 00613994837868: CUSTOM PACK 3R39R6 CORRUGATE
• 00613994793522: CUSTOM PACK 4D49R5 LEFT H BY
• 00613994776570: CUSTOM PACK 5W62R1 ALASKA REG
• 00613994761460: CUSTOM PACK 4D82R3 VENO-CIR-2
• 00613994748256: CUSTOM PACK 6N21R1 NO HEP MINI
• 00613994718471: CUSTOM PACK 5L87R1 KINETIC KIT
• 00613994711434: CUSTOM PACK 6G30R2 ECM
• 00613994691378: CUSTOM PACK 5386R16 PUMP-TABLE
• 00613994687852: CUSTOM PACK CB6L02R LFT HEART
• 00613994675712: ECMO PACK 2K88R1 PEDIATRIC
• 00613994675705: ECMO PACK 2K87R1 INFANT
• 00613994675699: ECMO PACK 2K85R1 ADULT
• 00613994667618: CUSTOM PACK 4B42R5 PBMS AD P-T
• 00613994661906: CUSTOM PACK 5U58R5 OP CORR SYS
• 00613994653192: CUSTOM PACK 5B29R1 ADULT PK
• 00613994642028: CUSTOM PACK 1N16R19 MAJOR NOCA
• 00613994639523: CUSTOM PACK 2U62R2 SUPPORT PK
• 00613994591210: CUSTOM PACK 6B79R2 HEART
• 00613994583642: CUSTOM PACK 6D44R TOTAL SYSTM
• 00613994579416: CUSTOM PACK CB5X67R2 MINI-CPT
• 00613994540300: CUSTOM PACK 5C36R3 REMOTE PACK
• 00613994538338: CUSTOM PACK 5Z17R1 IRRIGATION
• 00613994531049: CUSTOM PACK 2225R22 ADULT P/T
• 00613994526762: CUSTOM PACK 5646R12 WCH INF P
• 00613994513410: CUSTOM PACK 2375R9 PEDI P/T
• 00613994513342: CUSTOM PACK 2380R9 INFANT P/T
• 00613994507266: CUSTOM PACK 4W66R2 DAP PACK
• 00613994501974: CUSTOM PACK 5S16R BIO PUMP
• 00613994490902: CUSTOM PACK 0N70R18 HEART/L
• 00613994478498: CUSTOM PACK 5S30R1 1/8X3/16 AV
• 00613994466129: CUSTOM PACK 5C95R3 TABLE
• 00613994451774: CUSTOM PACK 5S12R HEART / L
• 00613994442871: CUSTOM PACK 5R36R1 RAP INF PCK
• 00613994439246: CUSTOM PACK 1845R32 BIOPUMP/T
• 00613994431134: CUSTOM PACK 0Z54R11 STBERN/DRA
• 00613994418173: CUSTOM PACK 5N64R SUPPORT PACK
• 00613994418166: CUSTOM PACK 5N63R ADULT CPS
• 00613994378545: CUSTOM PACK 5D56R5 NEURO FLOWS
• 00613994367617: CUSTOM PACK 4X35R1 BIO
• 00613994328625: CUSTOM PACK 5C45R3 H-L
• 00613994316424: CUSTOM PACK 5D44R PUMP
• 00613994286994: CUSTOM PACK 5B99R MASTER MEMB
• 00613994220424: CUSTOM PACK 3V39R1 L W/BP
• 00613994167842: CUSTOM PACK 4D85R3 PERF. W/BIO
• 00643169120198: CUSTOM PACK 3M16R13 PUMP / TBL