Intersept™

GUDID 20763000218595

CON CB4622 INTSPT BIOACT 1/2X3/8X3/8 10P

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set
Primary Device ID20763000218595
NIH Device Record Keyc08dfa21-038b-4bf1-9504-50b7440f5801
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntersept™
Version Model NumberCB4622
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter
Outer Diameter12.7 Millimeter
Outer Diameter9.5 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000218591 [Primary]
GS120763000218595 [Package]
Contains: 00763000218591
Package: PK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOXYGENATOR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-03-01

On-Brand Devices [Intersept™]

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

Trademark Results [Intersept]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTERSEPT
INTERSEPT
79232539 not registered Live/Pending
MITSUBISHI HEAVY INDUSTRIES, LTD.
2017-10-11
INTERSEPT
INTERSEPT
78224098 2860161 Dead/Cancelled
Novartis AG
2003-03-11
INTERSEPT
INTERSEPT
75135394 not registered Dead/Abandoned
International Sourcing, Inc.
1996-07-17
INTERSEPT
INTERSEPT
75046702 not registered Dead/Abandoned
Milliken & Company
1996-01-22
INTERSEPT
INTERSEPT
74730514 2045530 Dead/Cancelled
RPM Systems, Inc.
1995-09-18
INTERSEPT
INTERSEPT
73550512 1386665 Dead/Cancelled
UNITED MCGILL CORPORATION
1985-07-29
INTERSEPT
INTERSEPT
73514713 1357568 Live/Registered
INTERFACE, INC.
1984-12-21
INTERSEPT
INTERSEPT
73514713 1357568 Live/Registered
INTERFACE FLOORING SYSTEMS, INC.
1984-12-21
INTERSEPT
INTERSEPT
73170981 1128674 Live/Registered
CARPETS INTERNATIONAL-GEORGIA, INC.
1978-05-19
INTERSEPT
INTERSEPT
73031197 1010963 Dead/Expired
JOHNSON & JOHNSON
1974-09-05
INTERSEPT
INTERSEPT
73026434 1009488 Live/Registered
JOHNSON & JOHNSON
1974-07-10
INTERSEPT
INTERSEPT
72347552 0895349 Dead/Expired
JOHNSON & JOHNSON
1970-01-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.