Intersept™
GUDID 20763000218908
CON CB4634 INTSPT BIOACT 1/2X1/2 10PK
MEDTRONIC, INC.
Cardiopulmonary bypass system tubing set| Primary Device ID | 20763000218908 |
| NIH Device Record Key | 5f020eca-9e45-4aaa-8089-7efbbcdb3189 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intersept™ |
| Version Model Number | CB4634 |
| 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
Device Dimensions
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
| Outer Diameter | 12.7 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000218904 [Primary] |
| GS1 | 20763000218908 [Package] Contains: 00763000218904 Package: PK [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171979
FDA Product Code
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-09 |
| Device Publish Date | 2020-03-01 |
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 |
Trademark Results [Intersept]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERSEPT 79232539 not registered Live/Pending |
MITSUBISHI HEAVY INDUSTRIES, LTD. 2017-10-11 |
 INTERSEPT 78224098 2860161 Dead/Cancelled |
Novartis AG 2003-03-11 |
 INTERSEPT 75135394 not registered Dead/Abandoned |
International Sourcing, Inc. 1996-07-17 |
 INTERSEPT 75046702 not registered Dead/Abandoned |
Milliken & Company 1996-01-22 |
 INTERSEPT 74730514 2045530 Dead/Cancelled |
RPM Systems, Inc. 1995-09-18 |
 INTERSEPT 73550512 1386665 Dead/Cancelled |
UNITED MCGILL CORPORATION 1985-07-29 |
 INTERSEPT 73514713 1357568 Live/Registered |
INTERFACE, INC. 1984-12-21 |
INTERSEPT 73514713 1357568 Live/Registered |
INTERFACE FLOORING SYSTEMS, INC. 1984-12-21 |
 INTERSEPT 73170981 1128674 Live/Registered |
CARPETS INTERNATIONAL-GEORGIA, INC. 1978-05-19 |
 INTERSEPT 73031197 1010963 Dead/Expired |
JOHNSON & JOHNSON 1974-09-05 |
 INTERSEPT 73026434 1009488 Live/Registered |
JOHNSON & JOHNSON 1974-07-10 |
 INTERSEPT 72347552 0895349 Dead/Expired |
JOHNSON & JOHNSON 1970-01-02 |
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