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PUMP CBBP50 BIOPUMP 6HR CB PED ST 3L
MEDTRONIC, INC.
CBBP50
Not in Commercial Distribution
- 00613994413031 ()
- Cardiopulmonary bypass system centrifugal pump
PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK
MEDTRONIC, INC.
95201
In Commercial Distribution
- 20613994406945 ()
- 00613994406941 ()
- Cardiopulmonary bypass system centrifugal pump
The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
Zoll Circulation, Inc.
TG2-500D, Extended Length
In Commercial Distribution
- 00849111075879 ()
- Length: 9 Feet
8700-001028-01
- Intravascular core temperature regulation system start kit
The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
Zoll Circulation, Inc.
TG2-500D
In Commercial Distribution
- 00849111075862 ()
- Length: 6 Feet
8700-001027-01
- Intravascular core temperature regulation system start kit
TandemHeart blood pump
CARDIACASSIST, INC.
2100-0113
Not in Commercial Distribution
- 00814112020043 ()
- Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump/FloProbe Kit (Non-Sterile)
Not in Commercial Distribution
- 00814321020452 ()
6000N(KIT)
- Cardiopulmonary bypass system centrifugal pump
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6500N
Not in Commercial Distribution
- 00814321020445 ()
6500N
- Cardiopulmonary bypass system centrifugal pump
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6500S
Not in Commercial Distribution
- 00814321020438 ()
6500S
- Cardiopulmonary bypass system centrifugal pump
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6400N
Not in Commercial Distribution
- 00814321020148 ()
6400N
- Cardiopulmonary bypass system centrifugal pump
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6400S
Not in Commercial Distribution
- 00814321020131 ()
6400S
- Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
1/4" FloPump (Non-Sterile)
Not in Commercial Distribution
- 00814321020124 ()
6300N
- Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
1/4" FloPump (Sterile)
Not in Commercial Distribution
- 00814321020117 ()
6300S
- Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
1/4" FloPump/FloProbe Kit (Sterile)
Not in Commercial Distribution
- 00814321020100 ()
6300S(KIT)
- Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump/FloProbe Kit (Sterile)
Not in Commercial Distribution
- 00814321020094 ()
6000S(KIT)
- Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump (Sterile)
Not in Commercial Distribution
- 00814321020018 ()
6000S
- Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump (Non-Sterile)
Not in Commercial Distribution
- 00814321020001 ()
6000N
- Cardiopulmonary bypass system centrifugal pump
No Description
Spectranetics Corporation
423-050
In Commercial Distribution
- 00813132029951 ()
- Outer Diameter: 2.3 Millimeter
- Lumen/Inner Diameter: 0.018 Inch
- Length: 125 Centimeter
423-050
- Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
420-050
In Commercial Distribution
- 00813132029944 ()
- Outer Diameter: 2.0 Millimeter
- Lumen/Inner Diameter: 0.018 Inch
- Length: 150 Centimeter
420-050
- Atherectomy laser system beam guide-catheter, peripheral
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 401 is a set of nine individually packaged endotracheal tube changers, with each fitting a different size endotracheal tube. The JEM 401 includes one each of JEM 325, JEM 330, JEM 340, JEM 350, JEM 355, JEM 360, JEM 365, JEM 370, JEM 400.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 401
In Commercial Distribution
- M996JEM4010 ()
- Outer Diameter: 6.43 Millimeter
- Outer Diameter: 5.54 Millimeter
- Outer Diameter: 4.55 Millimeter
- Outer Diameter: 3.56 Millimeter
- Outer Diameter: 2.57 Millimeter
- Outer Diameter: 1.80 Millimeter
JEM 401
- Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 370 fits tubes with 7.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 370
In Commercial Distribution
- M996JEM3702 ()
- M996JEM3700 ()
- Outer Diameter: 5.54 Millimeter
JEM 370
- Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 360 fits tubes with 6.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 360
In Commercial Distribution
- M996JEM3602 ()
- M996JEM3600 ()
- Outer Diameter: 5.54 Millimeter
JEM 360
- Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 350 fits tubes with 5.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 350
In Commercial Distribution
- M996JEM3502 ()
- M996JEM3500 ()
- Outer Diameter: 4.55 Millimeter
JEM 350
- Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 330 fits tubes with 3.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 330
In Commercial Distribution
- M996JEM3302 ()
- M996JEM3300 ()
- Outer Diameter: 2.57 Millimeter
JEM 330
- Endotracheal tube guide, single-use
The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-152
Not in Commercial Distribution
- NRP368 ()
- Catheter Working Length: 150 Centimeter
- Lumen/Inner Diameter: .014 Inch
- Guidewire Compatibility: 4 French
R-410-152
- Atherectomy laser system beam guide-catheter, peripheral
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-154
Not in Commercial Distribution
- NRP130 ()
- Catheter Working Length: 150 Centimeter
- Lumen/Inner Diameter: .014 Inch
- Guidewire Compatibility: 4 French
- Atherectomy laser system beam guide-catheter, peripheral
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 400 fits tubes with 7.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 400
In Commercial Distribution
- M996JEM4002 ()
- M996JEM4000 ()
- Outer Diameter: 6.43 Millimeter
JEM 400
- Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 365 fits tubes with 6.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 365
In Commercial Distribution
- M996JEM3652 ()
- M996JEM3650 ()
- Outer Diameter: 5.54 Millimeter
JEM 365
- Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 355 fits tubes with 5.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 355
In Commercial Distribution
- M996JEM3552 ()
- M996JEM3550 ()
- Outer Diameter: 4.55 Millimeter
JEM 355
- Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 340 fits tubes with 4.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 340
In Commercial Distribution
- M996JEM3402 ()
- M996JEM3400 ()
- Outer Diameter: 3.56 Millimeter
JEM 340
- Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
JEM 325 fits tubes with 2.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 325
In Commercial Distribution
- M996JEM3252 ()
- M996JEM3250 ()
- Outer Diameter: 1.80 Millimeter
JEM 325
- Endotracheal tube guide, single-use
No Description
Thoratec Switzerland GmbH
201-90052
In Commercial Distribution
- 07640135140634 ()
201-90052
- Cardiopulmonary bypass system centrifugal pump
Blood Pump
Thoratec Switzerland GmbH
102953
In Commercial Distribution
- 07640135140627 ()
102953
- Cardiopulmonary bypass system centrifugal pump
No Description
Spectranetics Corporation
420-050
In Commercial Distribution
- 00813132026783 ()
- Outer Diameter: 2.0 Millimeter
- Length: 150 Centimeter
420-050
- Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
423-050
In Commercial Distribution
- 00813132026776 ()
- Outer Diameter: 2.3 Millimeter
- Length: 125 Centimeter
423-050
- Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
423-050AA
In Commercial Distribution
- 00813132025397 ()
- Outer Diameter: 2.3 Millimeter
423-050
- Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050AA
In Commercial Distribution
- 00813132025366 ()
- Outer Diameter: 2.0 Millimeter
420-050
- Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050
In Commercial Distribution
- 00813132024833 ()
- Outer Diameter: 2.0 Millimeter
420-050
- Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
425-135-01
In Commercial Distribution
- 00813132024819 ()
- Outer Diameter: 2.6 Millimeter
- Length: 112 Centimeter
425-135-01
- Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
423-135-01
In Commercial Distribution
- 00813132024796 ()
- Outer Diameter: 2.3 Millimeter
- Length: 125 Centimeter
423-135-01
- Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
425-011
In Commercial Distribution
- 00813132024789 ()
- Outer Diameter: 2.6 Millimeter
- Length: 112 Centimeter
425-011
- Atherectomy laser system beam guide-catheter, peripheral