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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Quantum - 05060434422316

Quantum Pump Frame 6 - Toronto
SPECTRUM MEDICAL LIMITED
QPF6
In Commercial Distribution

  • 05060434422316 ()
51-000095-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434422262

Quantum Pump Frame 5 - Charlotte
SPECTRUM MEDICAL LIMITED
QPF5
In Commercial Distribution

  • 05060434422262 ()
51-000090-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434422040

Quantum Pump Frame 2 - Cheltenham
SPECTRUM MEDICAL LIMITED
QPF2
In Commercial Distribution

  • 05060434422040 ()
51-000025-01

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434422026

Quantum Workstation Lite - 15"
SPECTRUM MEDICAL LIMITED
QWSL
In Commercial Distribution

  • 05060434422026 ()
51-000080-00

  • Cardiopulmonary bypass system roller pump

Adult Custom Pack - 00607567202993

701053325 BEQ-HMOD 70000-USA Adult Quadrox iD 701020489 BEQ-RF32 RotaFlow 701045763 Gas Filter
DATASCOPE CORP.
BEQ-TOP- 32100
Not in Commercial Distribution

  • 00607567202993 ()
701054438

  • Cardiopulmonary bypass system roller pump

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026530

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05060150
In Commercial Distribution

  • 04543660026530 ()
LA18-05060150

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026523

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05060100
In Commercial Distribution

  • 04543660026523 ()
LA18-05060100

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026516

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05050150
In Commercial Distribution

  • 04543660026516 ()
LA18-05050150

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026509

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05050100
In Commercial Distribution

  • 04543660026509 ()
LA18-05050100

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026493

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 150mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05040150
In Commercial Distribution

  • 04543660026493 ()
LA18-05040150

  • Peripheral angioplasty balloon catheter, basic
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