FDA.reportPublic FDA data

SUPPLEMENTAL VALVE LINE, ME

Primary DI
B066H73950
Brand
SUPPLEMENTAL VALVE LINE, ME
Company
NOVOSCI CORP.
Model
H-7395
Catalog number
H-7395
Device description
A 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.
Published
2015-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial LineCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K820472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K820472000WILLIAM HARVEY H-625 ARTERIAL FILTERC.R. Bard, Inc.1982-03-15DTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B066H73953PackageHIBCC20In Commercial Distribution
B066H73950PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
800-854-0567info@novosci.com

Regulatory Flags#

DUNS number
938289980
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0662010110000STOPCOCK, TMP 3-WAY W/LUER LOCK201011-000201011-0002015-09-14
B0662010120000STOPCOCK, TMP 4-WAY W/LUER LOCK201012-000201012-0002015-09-14
B0663110330000TUBING ORGANIZER - STERILE311033-000311033-0002015-10-06
B066311033NS1TUBING ORGANIZER - NON-STERILE 311033NS311033NS2015-10-13
B0663110340000PEDIATRIC TUBING ORGANIZER - STERILE311034-000311034-0002015-10-12
B066311034NS1PEDIATRIC TUBING ORGANIZRER - NON-STERILE311034NS311034NS2015-10-13
B066321244NS1"CONNECTOR, 1/4"" X 1/2"" X 1/2"" CLEAR PAY "321244NS321244NS2015-10-13
B066201006NS1CANNULAE, SAPHENOUS VEIN201006NS201006NS2015-11-11
B066301011NS1"QUICKIE PRIME - 1/4"" x 1/16"""301011NS301011NS2017-12-06
B066331011NS1"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE "331011NS331011NS2015-10-13
B066331012NS1"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE"331012NS331012NS2015-10-13
B066331022NS1"CONNECTOR, 1/4"" X 1/4"" W/OUT PART LINE"331022NS331022NS2015-10-13
B066331023NS1"CONNECTOR, 1/4"" X 3/8"" W/OUT PART LINE"331023NS331023NS2015-10-13
B066331024NS1"CONNECTOR, 1/4"" X 1/2"" W/OUT LUER "331024NS331024NS2015-10-13
B066331033NS1"CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE"331033NS331033NS2015-10-13
B066331034NS1"CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE"331034NS331034NS2015-10-13
B066331044NS1"CONNECTOR, 1/2"" X 1/2"" W/OUT PART LINE"331044NS331044NS2015-10-13
B066332011NS1"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE W/LUER"332011NS332011NS2015-10-13
B066332012NS1"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE W/LUER"332012NS332012NS2015-10-13
B066332022NS1"CONNECTOR, 1/4"" X 1/4"" W/LUER"332022NS332022NS2015-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117372446TRILLYEUROSETS SRLDTM2026-05-05
08054117372545HORIZONEUROSETS SRLDTM2026-05-05
B00962623OCS HEART LEUKOCYTE DEPLETING FILTERTRANSMEDICS, INC.DTM2026-05-04
08033178112857KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178112871KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178114561MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114578MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114608MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114562MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114579MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114609MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178113342INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
08033178113359INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
38033178113343INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
04037691180038PLEGIOX Heat Exchanger with CardioplegiaMaquet Cardiopulmonary AGDTM2017-05-02
04037691253862QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691173412QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691117911QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691229591PLEGIOX Cardioplegia Heat Exchanger Maquet Cardiopulmonary AGDTM2017-03-13
04058863017341QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863017372QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019055QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019079QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019147QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019185QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019000QUADROX-iDMaquet Cardiopulmonary AGDTM2017-02-16
04058863019024QUADROX-iDMaquet Cardiopulmonary AGDTM2017-02-16
04058863019154QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019178QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16