Intersept®

GUDID 00613994675675

CUSTOM PACK CB6H78R INFANTECMO

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00613994675675
• NIH Device Record Key: 28a09245-ec19-4311-830b-16338e63d394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intersept®
• Version Model Number: CB6H78R
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994675675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891687

FDA Product Code

• DTZ: OXYGENATOR, CARDIOPULMONARY BYPASS

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: 2015-06-11

On-Brand Devices [Intersept®]

• 20673978546265: TUBING 3506 INTERSEPT 6' 3/8X3/32, 10PK
• 20673978545909: TUBING 3008 3/16x1/16x8 FT
• 00613994937797: CUSTOM PACK 5A45R3 PERFUSION
• 20613994897118: CUSTOM PACK 6W04R1 5PK SUCKER
• 20613994870470: CUSTOM PACK 6T05R2 20PK VRV 100
• 20613994851424: CUSTOM PACK 1E35R6 2PK SUP AV LOOP
• 20613994778844: CUSTOM PACK 4M35R1 2PK TBLE10061LK
• 20613994764342: CUSTOM PACK 2K53R2 5PK CIRCULATORY
• 00613994758118: CUSTOM PACK 5F95R2 HPH 1400
• 00613994747631: CUSTOM PACK 6M95R3 MYOTHERM
• 00613994736994: CUSTOM PACK CB4G21R19 1/4 NEO
• 20613994703174: CUSTOM PACK 6G28R4 5PK EXTRA SUCKE
• 20613994688754: CUSTOM PACK 6G97R 5PK SUCKER PK
• 00613994675675: CUSTOM PACK CB6H78R INFANTECMO
• 00613994675668: CUSTOM PACK CB6H77R ADULT ECMO
• 00613994675651: CUSTOM PACK CB6H76R PED ECMO
• 20613994660422: CUSTOM PACK 6G50R1 5PK 1/2X3/8X3/8
• 20613994581734: CUSTOM PACK 6C78R 5PK 3/8 RACEWAY
• 00613994556370: CUSTOM PACK 6A97R CRDIO TRNP
• 00613994551306: CUSTOM PACK 2H08R3 LB SUPPORT
• 20613994545019: CUSTOM PACK 3V52R2 3PK HPH JUNIOR
• 20613994529088: RESERVOIR CB1351 BIOACT CARDIOTOM US 6PK
• 00613994517104: CUSTOM PACK 5M10R5 HCT KIT
• 00613994492166: CUSTOM PACK 5T72R2 HITT
• 00613994478511: CUSTOM PACK 4J91R2 3/8 IN RCW
• 00613994473677: CUSTOM PACK 5S31R 1/4X3/8 PEDI
• 20613994463504: CUSTOM PACK 5V14R 2PK ADT AFF FILT
• 20613994463498: CUSTOM PACK 5V13R 2PK PED AFF FILT
• 00613994463418: CUSTOM PACK 5V15R PIN PUMP PK
• 00613994462985: CUSTOM PACK CB5U83R AV 3/8X3/8
• 00613994462978: CUSTOM PACK CB5U82R AV 3/8X1/2
• 00613994462961: CUSTOM PACK CB5U81R VAVDHL
• 00613994462954: CUSTOM PACK CB5U80R HL
• 20613994462835: CUSTOM PACK 5U84R 2PK 1/2 TMC
• 20613994462811: CUSTOM PACK CB5U87R 2PK CB 1/2 TMC
• 20613994462804: CUSTOM PACK CB5U89R 2PK CB 1/4 TMC
• 20613994462781: CUSTOM PACK 5U91R 3/8 2PK CDI
• 20613994462774: CUSTOM PACK CB5U88R 2PK CB 3/8 TMC
• 00613994462732: CUSTOM PACK 2R88R3 PUMP/TABL
• 20613994436034: CUSTOM PACK CB5R47R 4PK AFF PAF WB
• 20613994420071: CUSTOM PACK 9295R3 5PK BRIDGE
• 00613994412898: CUSTOM PACK 5P62R OPEN SYS NC
• 20613994408482: TUBING 3510S 3/8 X 3/32 X 10FT 10PK
• 20613994408420: CUSTOM PACK 3L37R3 4PK CSTMXP4-1B
• 20613994407485: TUBING 3508S 3/8 X 3/32 X 8FT 10PK
• 20613994407355: CUSTOM PACK 2307R2 10PK FEM PACK
• 20613994392064: CUSTOM PACK 4W38R3 2PK HEART PROC
• 20613994387534: CUSTOM PACK 5L69R 10PK VAVD
• 00613994379627: CUSTOM PACK 9239R26 HEART LUNG
• 20673978573537: PORT & PLUG XA6063 1/2X1/2 STR W/LL 20CT