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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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PRO-FUSE® - 00884908148923

9.6F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT SILICONE CATHETER W/5FSILICONE C Micro-Stick®INTRODUCER SE
Medical Components, Inc.
MIPP96AFS
Not in Commercial Distribution

  • 50884908148928 ()
  • 00884908148923 ()
MIPP96AFS

  • Vascular port/catheter

Arthrex® - 00888867286580

Thrombinator™ System
ARTHREX, INC.
ABS-10080
In Commercial Distribution

  • 00888867286580 ()
ABS-10080

  • Haematological concentrate system preparation kit, thrombin separation

Provent Sleep Therapy - 00868020000208

Provent 30 Night Standard Pack contains 30 Standard resistance Provent
PROVENT SLEEP THERAPY, LLC
CAT1105
In Commercial Distribution

  • 00868020000208 ()

  • Expiratory Resistance 3.0 >= x < 8.0 cm H2O at 50 mL/sec flow rate per nostril
CAT1105

  • Nasal dilator

LABSYSTEM™ PRO - 08714729882961

RF Filter Module For CLEARSIGN™ Amplifier
BOSTON SCIENTIFIC CORPORATION
M00420012300
In Commercial Distribution

  • 08714729882961 ()


  • Electronic signal frequency filter

IntellaTip MiFi™ Filter Module - 08714729854395

RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M0041212H0
In Commercial Distribution

  • 08714729854395 ()


  • Electronic signal frequency filter

IntellaTip MiFi™ Filter Module - 08714729847939

RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M00412120
In Commercial Distribution

  • 08714729847939 ()


  • Electronic signal frequency filter

AlcoMate - 00853464001416

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM3500FC
In Commercial Distribution

  • 00853464001416 ()
AKG-SM3500FC

  • Alcohol breath analyser

AlcoMate - 00853464001409

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM3100
In Commercial Distribution

  • 00853464001409 ()
AKG-SM3100

  • Alcohol breath analyser

AlcoMate - 00853464001393

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM600
In Commercial Distribution

  • 00853464001393 ()
AKG-SM600

  • Alcohol breath analyser

AlcoMate - 00853464001348

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM200
In Commercial Distribution

  • 00853464001348 ()
AKG-SM200

  • Alcohol breath analyser
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