Intersept® Custom Tubing Pack
GUDID 00613994951816
CUSTOM PACK 5347R7 MEMB W/BP80
MEDTRONIC, INC.
Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set| Primary Device ID | 00613994951816 |
| NIH Device Record Key | 01a7c5f2-11fe-464b-9930-d329db95a9f8 |
| Commercial Distribution Discontinuation | 2015-09-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Intersept® Custom Tubing Pack |
| Version Model Number | 5347R7 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994951816 [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 |
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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