Intersept®

Primary DI
00613994352811
Brand
Intersept®
Company
MEDTRONIC, INC.
Model
6037
Device description
CONNECTOR 6037 1/4X3/8X3/8 Y 20CT
Published
2016-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWETubing, Pump, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800178000EXTRACORP.'S INTERSEPT CUS. TUBING PK.Extracorporeal Medical Specialities, Inc.1980-02-21DWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20681490007911PackageGS120In Commercial Distribution
00613994352811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149000791120681490007911
00613994352811006139943528116139943528110613994352811

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H965252810AngioVacNAVILYST MEDICAL, INC.DWE2020-05-11
0061625802153948” (122 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2019-10-25
0061625800850948” (122 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
0061625800851630” (76 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
0061625800852320” (50 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
0061625800853010” (25 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
00643169137653NAMEDTRONIC, INC.DWE2016-07-23
00643169169593NAMEDTRONIC, INC.DWE2016-06-11
00643169229136NAMEDTRONIC, INC.DWE2016-06-11
00643169019287INTERSEPT®MEDTRONIC, INC.DWE2016-06-06
00643169029293NAMEDTRONIC, INC.DWE2016-06-06
00613994363220Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994363237Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994407351INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994407481Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994408426INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994408488Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994462831INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994463494INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994851420INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994897114INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994946317Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994946331Intersept®MEDTRONIC, INC.DWE2016-05-28
00643169021358INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169029125INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169061866INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169096837INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00643169096905INTERSEPT®MEDTRONIC, INC.DWE2016-05-28
00613994097408NAMEDTRONIC, INC.DWE2016-05-22
00613994117175NAMEDTRONIC, INC.DWE2016-05-22