FDA.report

NOVOSCI CORP.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
16255191625519NOVOSCI CORP.1Y2026-01-012021 Airport Road Conroe TX US 77301

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
B0662010110000STOPCOCK, TMP 3-WAY W/LUER LOCK - 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.800-854-0567info@novosci.com
B0663010100000CONNECTOR, 3/8" PERFUSION ADAPTER - 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 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.800-854-0567info@novosci.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
220021322108875K990514MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VRDTP1999-03-09
220021739771151K912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTDXS1991-10-31
220021136109643K821495DISPOSABLE BLOOD LINE CONNECTORSKOC1982-05-27
220021221535812K820472WILLIAM HARVEY H-625 ARTERIAL FILTERDTM1982-03-15
220022031824359K810532DISPOSABLE STOPCOCKDTZ1981-04-23
220021621595846K802545CARDIOPLEGIC SETSDTR1981-01-16
220021753455549K802542DISPOSABLE CONNECTORSKRI1981-01-16
220021698840134K802541DISPOSABLE PARALLEL Y CONNECTORSKRI1981-01-16
220022034282492K801405DISPOSABLE PERFUSION CONNECTORSDTL1980-06-30
220021165302572K801404DISPOSABLE PARALLEL Y CONNECTORSDTL1980-06-30
220021623820540K801403DISPOSABLE PERFUSION SETDWF1980-06-30
220021706079503K801402QUICKIE PRIME CARDIOP. BYPASS PERF. INTRDTL1980-06-30
220021139058154K801401CARDIOPULMONARY BYPASS TUBINGDWF1980-06-30
220021885042538K801400DISPOSABLE SUCKER SYSTEMDTS1980-06-30
220021666786646K801399CORONARY PERFUSION CONNECTOR PLUGDTL1980-06-30
220021669060966K801397VENA CAVA CANNULAEDWF1980-06-30
220021349753480K801396SAPHENOUS VEIN CANNULAEDWF1980-06-30
220021515067245K801395VASCULAR CLAMPDXC1980-06-30
220021966099983K801393AIR ASPIRATOR NEEDLEDWS1980-06-30
220021928586540K801392DISPOSABLE SUMP SETSDWF1980-06-30
220021651114094K770707TYGON PAC-MONITORING LINES & FLUID ADMINFMG1977-06-03
220021207918126

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DWF51980-06-30
DTL41980-06-30
KRI21981-01-16
DTP11999-03-09
DXS11991-10-31
KOC11982-05-27
DTM11982-03-15
DTZ11981-04-23
DTR11981-01-16
DTS11980-06-30
DXC11980-06-30
DWS11980-06-30
FMG11977-06-03

PMN

GUDID

QUICKIE PRIME - 24" W/CLAMP - A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Adult Grooved Tip Sucker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Pediatric Grooved Tip Sucker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Infant Grooved Tip Sucker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Left Heart Sump - 45 Degree - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2017-02-14

Left Heart Sump 90 Degrees - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Adult Sump Sucker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Aortic Sump Set - Adult - A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation, ENT, neuro and general surgery). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Hex Handle Grooved Tip Sucker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Hex Handle Debridement Sucker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Hex Handle Tip Sucker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Hex Handle Adult Sump SUcker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Hex Handle Tip Sucker W/Vent - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Tonsil Tip Sucker - A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

2016-09-26

Suction Forceps Adapter - A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation, ENT, neuro and general surgery). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single-use device.

NOVOSCI CORP.

2016-09-26

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