FDA.reportPublic FDA data

STOPCOCK, TMP 4-WAY W/LUER LOCK

Primary DI
B0662010120000
Brand
STOPCOCK, TMP 4-WAY W/LUER LOCK
Company
NOVOSCI CORP.
Model
201012-000
Catalog number
201012-000
Device description
A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.
Published
2015-09-14
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
DTZOxygenator, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K810532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810532000DISPOSABLE STOPCOCKTexas Medical Products, Inc.1981-04-23DTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0662010120003PackageHIBCC25In Commercial Distribution
B0662010120005PackageHIBCC100In Commercial Distribution
B0662010120006PackageHIBCC50In Commercial Distribution
B0662010120007PackageHIBCC75In Commercial Distribution
B0662010120000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Sterilization Methods#

Method table
Method

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
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
B066332023NS1"CONNECTOR, 1/4"" X 3/8"" W/O PART LINE W/LUER"332023NS332023NS2015-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08054117372446TRILLYEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
18051160302762Quantum Perfusion Blood Oxygenator VT200-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160302779Quantum Perfusion Blood Oxygenator VT160-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
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08033178113342INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
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08033178113366INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
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08033178113236INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
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