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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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ARROW - 30801902092145

AEROAUTOCAT2 DUTCH
TELEFLEX INCORPORATED
IPN000318
In Commercial Distribution

  • 30801902092145 ()
  • 00801902092144 ()
IAP-0435NL

  • Intra-aortic balloon pump

ARROW - 30801902092138

AEROAUTOCAT2 JAPANESE
TELEFLEX INCORPORATED
IPN000317
In Commercial Distribution

  • 30801902092138 ()
  • 00801902092137 ()
IAP-0435J

  • Intra-aortic balloon pump

ARROW - 30801902092121

AEROAUTOCAT2 ITALIAN
TELEFLEX INCORPORATED
IPN000316
In Commercial Distribution

  • 30801902092121 ()
  • 00801902092120 ()
IAP-0435I

  • Intra-aortic balloon pump

ARROW - 30801902092114

AEROAUTOCAT2 FRENCH
TELEFLEX INCORPORATED
IPN000315
In Commercial Distribution

  • 30801902092114 ()
  • 00801902092113 ()
IAP-0435F

  • Intra-aortic balloon pump

ARROW - 30801902092107

AEROAUTOCAT2 GERMAN
TELEFLEX INCORPORATED
IPN000313
In Commercial Distribution

  • 30801902092107 ()
  • 00801902092106 ()
IAP-0435D

  • Intra-aortic balloon pump

ARROW - 30801902092091

N/A
TELEFLEX INCORPORATED
IPN000314
In Commercial Distribution

  • 30801902092091 ()
  • 00801902092090 ()
IAP-0435E

  • Intra-aortic balloon pump

ARROW - 30801902092084

AUTOCAT2 SWEDISH
TELEFLEX INCORPORATED
IPN000310
In Commercial Distribution

  • 30801902092084 ()
  • 00801902092083 ()
IAP-0400SV

  • Intra-aortic balloon pump

ARROW - 30801902092077

AUTOCAT2 DUTCH
TELEFLEX INCORPORATED
IPN000309
In Commercial Distribution

  • 30801902092077 ()
  • 00801902092076 ()
IAP-0400NL

  • Intra-aortic balloon pump

ARROW - 30801902092060

AUTOCAT2 ITALIAN
TELEFLEX INCORPORATED
IPN000307
In Commercial Distribution

  • 30801902092060 ()
  • 00801902092069 ()
IAP-0400I

  • Intra-aortic balloon pump

ARROW - 30801902092053

AUTOCAT2 FRENCH
TELEFLEX INCORPORATED
IPN000306
In Commercial Distribution

  • 30801902092053 ()
  • 00801902092052 ()
IAP-0400F

  • Intra-aortic balloon pump

ARROW - 30801902092046

N/A
TELEFLEX INCORPORATED
IPN000304
In Commercial Distribution

  • 30801902092046 ()
  • 00801902092045 ()
IAP-0400D

  • Intra-aortic balloon pump

ARROW - 30801902092039

AUTOCAT2 SPANISH
TELEFLEX INCORPORATED
IPN000305
In Commercial Distribution

  • 30801902092039 ()
  • 00801902092038 ()
IAP-0400E

  • Intra-aortic balloon pump

ARROW - 30801902091803

AEROAUTOCAT2 WAVE SWEDISH
TELEFLEX INCORPORATED
IPN000336
In Commercial Distribution

  • 30801902091803 ()
  • 00801902091802 ()
IAP-0535SV

  • Intra-aortic balloon pump

ARROW - 30801902091797

AEROAUTOCAT2 WAVE DUTCH
TELEFLEX INCORPORATED
IPN000335
In Commercial Distribution

  • 30801902091797 ()
  • 00801902091796 ()
IAP-0535NL

  • Intra-aortic balloon pump

ARROW - 30801902091780

AEROAUTOCAT2 WAVE JAPANES
TELEFLEX INCORPORATED
IPN000334
In Commercial Distribution

  • 30801902091780 ()
  • 00801902091789 ()
IAP-0535J

  • Intra-aortic balloon pump

ARROW - 30801902091773

AEROAUTOCAT2 WAVE ITALIAN
TELEFLEX INCORPORATED
IPN000333
In Commercial Distribution

  • 30801902091773 ()
  • 00801902091772 ()
IAP-0535I

  • Intra-aortic balloon pump

ARROW - 30801902091766

AEROAUTOCAT2 WAVE FRENCH
TELEFLEX INCORPORATED
IPN000332
In Commercial Distribution

  • 30801902091766 ()
  • 00801902091765 ()
IAP-0535F

  • Intra-aortic balloon pump

ARROW - 30801902091759

AEROAUTOCAT2 WAVE GERMAN
TELEFLEX INCORPORATED
IPN000330
In Commercial Distribution

  • 30801902091759 ()
  • 00801902091758 ()
IAP-0535D

  • Intra-aortic balloon pump

ARROW - 30801902091742

AEROAUTOCAT2 WAVE SPANISH
TELEFLEX INCORPORATED
IPN000331
In Commercial Distribution

  • 30801902091742 ()
  • 00801902091741 ()
IAP-0535E

  • Intra-aortic balloon pump

ARROW - 30801902091735

AUTOCAT2 WAVE SWEDISH
TELEFLEX INCORPORATED
IPN000327
In Commercial Distribution

  • 30801902091735 ()
  • 00801902091734 ()
IAP-0500SV

  • Intra-aortic balloon pump

ARROW - 30801902091728

AUTOCAT2 WAVE DUTCH
TELEFLEX INCORPORATED
IPN000326
In Commercial Distribution

  • 30801902091728 ()
  • 00801902091727 ()
IAP-0500NL

  • Intra-aortic balloon pump

ARROW - 30801902051746

AEROAUTOCAT2
TELEFLEX INCORPORATED
IPN000312
In Commercial Distribution

  • 30801902051746 ()
  • 00801902051745 ()
IAP-0435

  • Intra-aortic balloon pump

ARROW - 30801902051739

AEROAUTOCAT 2 WAVE
TELEFLEX INCORPORATED
IPN000329
In Commercial Distribution

  • 30801902051739 ()
  • 00801902051738 ()
IAP-0535

  • Intra-aortic balloon pump

ARROW - 30801902051722

AUTOCAT 2
TELEFLEX INCORPORATED
IPN000302
In Commercial Distribution

  • 30801902051722 ()
  • 00801902051721 ()
IAP-0400

  • Intra-aortic balloon pump

ARROW - 30801902051715

AUTOCAT2 WAVE
TELEFLEX INCORPORATED
IPN000320
In Commercial Distribution

  • 30801902051715 ()
  • 00801902051714 ()
IAP-0500

  • Intra-aortic balloon pump

ARROW - 30801902043420

AUTOCAT2 WAVE JAPANESE
TELEFLEX INCORPORATED
IPN000325
In Commercial Distribution

  • 30801902043420 ()
  • 00801902043429 ()
IAP-0500J

  • Intra-aortic balloon pump

ARROW - 30801902043413

AUTOCAT2 JAPANESE
TELEFLEX INCORPORATED
IPN000308
In Commercial Distribution

  • 30801902043413 ()
  • 00801902043412 ()
IAP-0400J

  • Intra-aortic balloon pump

De Soutter Medical - 05051471116856

ECO PULSE - FEMORAL CANAL NOZZLE WITHOUT SUCTION
DE SOUTTER MEDICAL LIMITED
P20-122
Not in Commercial Distribution

  • 05051471116856 ()
  • 15051471116853 ()
P20-122

  • Surgical irrigation system nozzle

PERMA PURE - 00840106905591

ME Dryer with Male Luer Fittings
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 10840106905598 ()
  • 00840106905591 ()
ME-050-03-58

  • Gas-sampling/monitoring respiratory tubing, single-use

TempAlert II - 10815236020343

TempAlert II Liquid Crystal Temperature Trend Indicator
LCR HALLCREST, LLC.
8501SD-II
In Commercial Distribution

  • 20815236020340 ()
  • 10815236020343 ()
  • 00815236020346 ()
SSH15491

  • Liquid-crystal patient thermometer, single-use

SpO2.COM® NRC-SL2 Spacelabs Replacement Cable - 00843997001434

No Description
MASIMO CORPORATION
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-P8 Patient Cable, 3M - 00843997001427

No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-SL Spacelabs Replacement Cable - 00843997001410

No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® Infant SpO2 disposable sensor - 10843997000472

No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use

SpO2.COM® pediatric SpO2 disposable sensor - 10843997000489

No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use

SpO2.COM® adult SpO2 disposable sensor - 10843997000465

No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use

PABLO - 09120077180151

PABLO is a modern therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.
tyromotion GmbH
5
In Commercial Distribution

  • 09120077180151 ()


  • Virtual-display rehabilitation system, non-supportive, clinical

TYMO - 09120077180045

The TYMO system is a modern monitoring and therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.
tyromotion GmbH
5
In Commercial Distribution

  • 09120077180045 ()


  • Virtual-display rehabilitation system, non-supportive, clinical

suiteHEART - 00850001088015

suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution

  • 00850001088015 ()


  • MRI system application software

MANI CARBIDE BURS - 04546951534189

MANI CARBIDE BURS
MANI, INC.
5
In Commercial Distribution

  • 74546951534188 ()
  • 04546951534189 ()


  • Carbide dental bur, reusable
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