novosci.comNOVOFLO CATHETER LT
NOVOSCI, INC.
NOVOSCI CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1625519 | 1625519 | NOVOSCI CORP. | 1 | Y | 2026-01-01 | 2021 Airport Road Conroe TX US 77301 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B066201006NS1 | CANNULAE, SAPHENOUS VEIN - A single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device. | 800-854-0567 | info@novosci.com |
| B0662010110000 | STOPCOCK, 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. | 800-854-0567 | info@novosci.com |
| B0662010120000 | STOPCOCK, TMP 4-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. | 800-854-0567 | info@novosci.com |
| B0663110330000 | TUBING ORGANIZER - STERILE - A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device. | 800-854-0567 | info@novosci.com |
| B066311033NS1 | TUBING ORGANIZER - NON-STERILE - A small, non-sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device intended to be sterilized prior to use. | 800-854-0567 | info@novosci.com |
| B066311034NS1 | PEDIATRIC TUBING ORGANIZRER - NON-STERILE - A small, non-sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device intended to be sterilized prior to use. | 800-854-0567 | info@novosci.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 22002 | 1322108875 | K990514 | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | DTP | 1999-03-09 |
| 22002 | 1739771151 | K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | DXS | 1991-10-31 |
| 22002 | 1136109643 | K821495 | DISPOSABLE BLOOD LINE CONNECTORS | KOC | 1982-05-27 |
| 22002 | 1221535812 | K820472 | WILLIAM HARVEY H-625 ARTERIAL FILTER | DTM | 1982-03-15 |
| 22002 | 2031824359 | K810532 | DISPOSABLE STOPCOCK | DTZ | 1981-04-23 |
| 22002 | 1621595846 | K802545 | CARDIOPLEGIC SETS | DTR | 1981-01-16 |
| 22002 | 1753455549 | K802542 | DISPOSABLE CONNECTORS | KRI | 1981-01-16 |
| 22002 | 1698840134 | K802541 | DISPOSABLE PARALLEL Y CONNECTORS | KRI | 1981-01-16 |
| 22002 | 2034282492 | K801405 | DISPOSABLE PERFUSION CONNECTORS | DTL | 1980-06-30 |
| 22002 | 1165302572 | K801404 | DISPOSABLE PARALLEL Y CONNECTORS | DTL | 1980-06-30 |
| 22002 | 1623820540 | K801403 | DISPOSABLE PERFUSION SET | DWF | 1980-06-30 |
| 22002 | 1706079503 | K801402 | QUICKIE PRIME CARDIOP. BYPASS PERF. INTR | DTL | 1980-06-30 |
| 22002 | 1139058154 | K801401 | CARDIOPULMONARY BYPASS TUBING | DWF | 1980-06-30 |
| 22002 | 1885042538 | K801400 | DISPOSABLE SUCKER SYSTEM | DTS | 1980-06-30 |
| 22002 | 1666786646 | K801399 | CORONARY PERFUSION CONNECTOR PLUG | DTL | 1980-06-30 |
| 22002 | 1669060966 | K801397 | VENA CAVA CANNULAE | DWF | 1980-06-30 |
| 22002 | 1349753480 | K801396 | SAPHENOUS VEIN CANNULAE | DWF | 1980-06-30 |
| 22002 | 1515067245 | K801395 | VASCULAR CLAMP | DXC | 1980-06-30 |
| 22002 | 1966099983 | K801393 | AIR ASPIRATOR NEEDLE | DWS | 1980-06-30 |
| 22002 | 1928586540 | K801392 | DISPOSABLE SUMP SETS | DWF | 1980-06-30 |
| 22002 | 1651114094 | K770707 | TYGON PAC-MONITORING LINES & FLUID ADMIN | FMG | 1977-06-03 |
| 22002 | 1207918126 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DWF | 5 | 1980-06-30 |
| DTL | 4 | 1980-06-30 |
| KRI | 2 | 1981-01-16 |
| DTP | 1 | 1999-03-09 |
| DXS | 1 | 1991-10-31 |
| KOC | 1 | 1982-05-27 |
| DTM | 1 | 1982-03-15 |
| DTZ | 1 | 1981-04-23 |
| DTR | 1 | 1981-01-16 |
| DTS | 1 | 1980-06-30 |
| DXC | 1 | 1980-06-30 |
| DWS | 1 | 1980-06-30 |
| FMG | 1 | 1977-06-03 |
PMN#
D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW
NOVOSCI CORP.
NOVOSCI READY SYSTEM, MODEL RS-200
NOVOSCI CORP.
GUDID#
STOPCOCK, 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.
2015-09-14
STOPCOCK, TMP 4-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.
2015-09-14
TUBING ORGANIZER - STERILE - A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device.
2015-10-06
TUBING ORGANIZER - NON-STERILE - A small, non-sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device intended to be sterilized prior to use.
2015-10-13
PEDIATRIC TUBING ORGANIZER - STERILE - A small, sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device.
2015-10-12
PEDIATRIC TUBING ORGANIZRER - NON-STERILE - A small, non-sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device intended to be sterilized prior to use.
2015-10-13
"CONNECTOR, 1/4"" X 1/2"" X 1/2"" CLEAR PAY " - A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
2015-10-13
CANNULAE, SAPHENOUS VEIN - A single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.
2015-11-11
"QUICKIE PRIME - 1/4"" x 1/16""" - 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.
2017-12-06
"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE " - 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.
2015-10-13
"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE" - 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.
2015-10-13
"CONNECTOR, 1/4"" X 1/4"" W/OUT PART LINE" - 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.
2015-10-13
"CONNECTOR, 1/4"" X 3/8"" W/OUT PART LINE" - 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.
2015-10-13
"CONNECTOR, 1/4"" X 1/2"" W/OUT LUER " - 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.
2015-10-13
"CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE" - 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.
2015-10-13
"CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE" - 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.
2015-10-13
"CONNECTOR, 1/2"" X 1/2"" W/OUT PART LINE" - A 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.
2015-10-13
"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE W/LUER" - 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.
2015-10-13
"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE W/LUER" - 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.
2015-10-13
"CONNECTOR, 1/4"" X 1/4"" W/LUER" - 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.
2015-10-13
"CONNECTOR, 1/4"" X 3/8"" W/O PART LINE W/LUER" - A 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.
2015-10-13
"CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE W/LUER" - 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.
2015-10-13
"CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE W/LUER" - 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.
2015-10-13
"CONNECTOR, 1/2"" X 1/2"" W/LUER" - 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.
2015-10-13
"CONNECTOR, Y 3/16"" X 3/16"" X 1/4"" W/OUT LUER" - 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.
2015-10-07
"CONNECTOR, Y 1/4"" X 1/4"" X 3/8"" W/OUT LUER" - 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.
2015-10-13
"CONNECTOR, Y 1/4"" X 3/8"" X 1/4"" W/OUT LUER" - 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.
2015-10-13
"CONNECTOR, Y 1/4"" X 3/8"" X 3/8"" W/OUT LUER" - 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.
2015-10-13
"CONNECTOR, Y 1/4"" X 1/2"" X 1/2"" W/OUT LUER" - 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.
2015-10-13
"CONNECTOR, Y 3/8"" X 3/8"" X 1/2"" W/OUT LUER" - 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.
2015-10-13
"CONNECTOR, Y 3/8"" X 1/2"" X 1/2"" W/OUT LUER" - A 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.
2015-10-13
"CONNECTOR, Y 1/2"" X 1/2"" X 1/2"" W/OUT LUER" - 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.
2015-10-13
"CONNECTOR, Y 3/16"" X 3/16"" X 1/4"" W/LUER" - 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.
2017-02-14
"CONNECTOR, Y 1/4"" X 1/4"" X 1/4"" W/LUER" - 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.
2015-10-14
"CONNECTOR, Y 1/4"" X 1/4"" X 3/8"" W/LUER" - 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.
2015-10-13
"CONNECTOR, Y 1/4"" X 3/8"" X 3/8"" W/LUER" - 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.
2016-03-07
"CONNECTOR, Y 3/8"" X 3/8"" X 3/8"" W/LUER" - 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.
2015-10-13
"CONNECTOR, Y 3/8"" X 1/2"" X 1/2"" W/LUER" - 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.
2015-10-13
"CONNECTOR, Y 1/2"" X 1/2"" X 1/2"" W/LUER" - 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.
2015-10-13
"CONNECTOR, Y 3/16"" X 3/16"" X 3/16"" W/OUT LUER" - A 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.
2015-10-13