FDA.reportPublic FDA data

Connector, 1/4" x 1/4" With Luer

Primary DI
B066332022000
Brand
Connector, 1/4" x 1/4" With Luer
Company
NOVOSCI CORP.
Model
332022-000
Catalog number
332022-000
Device description
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it
Published
2015-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0663320220003PackageHIBCC25In Commercial Distribution
B0663320220005PackageHIBCC100In Commercial Distribution
B0663320220006PackageHIBCC50In Commercial Distribution
B0663320220007PackageHIBCC75In Commercial Distribution
B066332022000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system tubing connectorA sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
938289980
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B066C345B1CONNECTOR, EQUAL Y 1/2" W/LUERC345BC345B2015-09-14
B0662010110000STOPCOCK, TMP 3-WAY W/LUER LOCK201011-000201011-0002015-09-14
B0663010100000CONNECTOR, 3/8" PERFUSION ADAPTER301010-000301010-0002015-10-06
B066341111NS1CONNECTOR, Y 3/16" x 3/16" x 3/16" W/O LUER341111NS341111NS2015-10-13
B066341222NS1CONNECTOR, Y 1/4" X 1/4" X 1/4"341222NS341222NS2015-10-13
B066341344NS5CONNECTOR, Y 3/8" x 1/2" x 1/2" W/O LUER341344NS341344NS2015-10-13
B066H11360STANDARD VAVD KITH-1136H-11362016-09-26
B0663011240000QUICKIE PRIME - 24" W/CLAMP301124-000301124-0002016-09-26
B0663320220000CONNECTOR, 1/4" x 1/4" W/LUER332022-000332022-0002015-10-06
B066C115S0CONNECTOR, STRAIGHT 3/16" x 3/16" W/LUERC115SC115S2015-09-14
B0662010350006Adult Grooved Tip Sucker201035-000201035-0002016-09-26
B0662010360006Pediatric Grooved Tip Sucker201036-000201036-0002016-09-26
B0662010370006Infant Grooved Tip Sucker201037-000201037-0002016-09-26
B0662010440006Left Heart Sump - 45 Degree201044-000201044-0002017-02-14
B0662010890006Left Heart Sump 90 Degrees201089-000201089-0002016-09-26
B0662010900006Adult Sump Sucker201090-000201090-0002016-09-26
B0662010950006Aortic Sump Set - Adult201095-000201095-0002016-09-26
B0662011350006Hex Handle Grooved Tip Sucker201135-000201135-0002016-09-26
B0662011640006Hex Handle Debridement Sucker201164-000201164-0002016-09-26
B0662011800006Hex Handle Tip Sucker201180-000201180-0002016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060434424457QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-20
05060434424532QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-09
05415067034441CentriMag™Thoratec CorporationKRI2026-02-02
08034013785489HOLDEREUROSETS SRLKRI2025-02-19
17290117830076INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
10850007732353VitalFlow CaddyMICHIGAN CRITICAL CARE CONSULTANTS, INC.KRI2024-09-19
25060434423966QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423973QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423980Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
08033178101547Sinergy and Mini Bag CPBSORIN GROUP ITALIA SRLKRI2023-10-24
08033178101622Vanguard, CSC 14 and HSCSORIN GROUP ITALIA SRLKRI2023-10-24
08033178102292DAC CardiotomySORIN GROUP ITALIA SRLKRI2023-10-24
08033178102384ExchangerSORIN GROUP ITALIA SRLKRI2023-10-24
08033178103428HemoconcentratorSORIN GROUP ITALIA SRLKRI2023-10-24
08033178109857D100/D101SORIN GROUP ITALIA SRLKRI2023-10-24
08033178109864D130/D131 KIDS Arterial FilterSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111959InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111966InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178112970InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178112987InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178112994InspireSORIN GROUP ITALIA SRLKRI2023-10-24
00850054036001VivaCartCARDIOQUIP, LLCKRI2023-10-02
00850054036018VivaCartCARDIOQUIP, LLCKRI2023-10-02
00850054036025VivaCartCARDIOQUIP, LLCKRI2023-10-02
00850054036032VivaCartCARDIOQUIP, LLCKRI2023-10-02
00850054036049VivaCartCARDIOQUIP, LLCKRI2023-10-02
00850054036056VivaCartCARDIOQUIP, LLCKRI2023-10-02
00850054036063VivaCartCARDIOQUIP, LLCKRI2023-10-02
00850054036070VivaCartCARDIOQUIP, LLCKRI2023-10-02
00850054036087VivaCartCARDIOQUIP, LLCKRI2023-10-02