Intersept™

GUDID 20643169767212

CON CB4619 INTSPT BIOACT 3/16X3/16 10PK

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 20643169767212
• NIH Device Record Key: 165e8862-a86b-4935-85f2-11796c4ac080
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intersept™
• Version Model Number: CB4619
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	00643169767201 [Primary]
GS1	20643169767212 [Package]; Contains: 00643169767201; Package: PK [10 Units]; In Commercial Distribution

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: 2017-01-21

On-Brand Devices [Intersept™]

• 20643169767656: RSVR 1351 INTERS CARDIOTOMY W/FILTER 6PK
• 20643169767618: RESERV CB1351 BIOACT CARDIOTOMY 6PK
• 20643169767496: CON CB4634 INTSPT BIOACT 1/2X1/2 10PK
• 20643169767472: CON CB4633 INTSPT BIOACT 1/2X3/8 10PK
• 20643169767458: CON CB4632 INTSPT BIOACT 3/8X1/4 10PK
• 20643169767434: CON CB4631 INTSPT BIOACT 1/4X3/16 10 PK
• 20643169767410: CON CB4630 INTSPT BIOACT 1/4X1/4 LL 10PK
• 20643169767397: CON CB4629 INTSPT BIOACT 1/4X1/4 10PK
• 20643169767373: CON CB4628 INTSPT BIOACT 3/8 Y 10PK
• 20643169767359: CON CB4626 INTSPT BIOACT 1/4 Y 10PK
• 20643169767335: CON CB4625 INTSPT BIOACT 1/4 Y LL 10PK
• 20643169767311: CON CB4624 INTSPT BIOACT 3/8X3/8 10PK
• 20643169767298: CON CB4623 INTSPT BIOACT 3/8X3/8 LL 10PK
• 20643169767274: CON CB4622 INTSPT BIOACT 1/2X3/8X3/8 10P
• 20643169767250: CON CB4621 INTSPT BIOACT 1/2X1/2 LL 10PK
• 20643169767236: CON CB4620 INTSPT BIOACT 1/4X3/8 LL 10PK
• 20643169767212: CON CB4619 INTSPT BIOACT 3/16X3/16 10PK
• 20643169767199: CON CB4618 INTSPT BIOACT 3/8 Y LL 10PK
• 20643169767175: CON CB4617 INTSPT BIOACT 3/16X3/16LL10PK
• 20643169767151: CON CB4616 INTSPT BIOACT 1/2X3/8 LL 10PK
• 20643169767137: CON CB4615 INTSPT BIOACT 1/4X3/16 10PK
• 20643169767113: CON CB4614 INTSPT BIOCT3/8X1/4X1/4Y 10PK
• 20643169767090: CON CB4613 INTSPT BIACT1/2X1/2X1/2Y 10PK
• 20643169767076: TUB CB2995 STER 72IN 1/2X3/32 5PK
• 20643169767052: TUB CB2994 STER 72IN 3/8X3/32 5PK
• 20643169767038: TUB CB2993 STER 72IN 1/4X1/16 5PK
• 00643169653313: RSVR 1351 INTERS CARDIOTOMY W/FILTER 6PK
• 20763000219134: TUB CB2995 STER 72IN 1/2X3/32 5PK
• 20763000219127: TUB CB2994 STER 72IN 3/8X3/32 5PK
• 20763000219103: TUB CB2993 STER 72IN 1/4X1/16 5PK
• 20763000218908: CON CB4634 INTSPT BIOACT 1/2X1/2 10PK
• 20763000218878: CON CB4633 INTSPT BIOACT 1/2X3/8 10PK
• 20763000218847: CON CB4632 INTSPT BIOACT 3/8X1/4 10PK
• 20763000218816: CON CB4631 INTSPT BIOACT 1/4X3/16 10 PK
• 20763000218793: CON CB4630 INTSPT BIOACT 1/4X1/4 LL 10PK
• 20763000218762: CON CB4629 INTSPT BIOACT 1/4X1/4 10PK
• 20763000218731: CON CB4628 INTSPT BIOACT 3/8 Y 10PK
• 20763000218700: CON CB4626 INTSPT BIOACT 1/4 Y 10PK
• 20763000218670: CON CB4625 INTSPT BIOACT 1/4 Y LL 10PK
• 20763000218656: CON CB4624 INTSPT BIOACT 3/8X3/8 10PK
• 20763000218625: CON CB4623 INTSPT BIOACT 3/8X3/8 LL 10PK
• 20763000218595: CON CB4622 INTSPT BIOACT 1/2X3/8X3/8 10P
• 20763000218564: CON CB4621 INTSPT BIOACT 1/2X1/2 LL 10PK
• 20763000218540: CON CB4620 INTSPT BIOACT 1/4X3/8 LL 10PK
• 20763000218519: CON CB4619 INTSPT BIOACT 3/16X3/16 10PK
• 20763000218496: CON CB4618 INTSPT BIOACT 3/8 Y LL 10PK
• 20763000218472: CON CB4617 INTSPT BIOACT 3/16X3/16LL10PK
• 20763000218458: CON CB4616 INTSPT BIOACT 1/2X3/8 LL 10PK
• 20763000218427: CON CB4615 INTSPT BIOACT 1/4X3/16 10PK
• 20763000218403: CON CB4614 INTSPT BIOCT3/8X1/4X1/4Y 10PK