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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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GeneXpert Infinity-80 System - 07332940006846

Additional catalog number: 900-0455R
CEPHEID
INFINITY 48-32
In Commercial Distribution

  • 07332940006846 ()
900-0455

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Infinity-80 System - 07332940006839

Additional catalog number: 900-0454R
CEPHEID
INFINITY 48-24
In Commercial Distribution

  • 07332940006839 ()
900-0454

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940004170

Additional catalog number: 900-0424R
CEPHEID
GXIV-2
In Commercial Distribution

  • 07332940004170 ()
900-0424

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940001469

Additional catalog number: 900-0519R
CEPHEID
GXXVI-8
Not in Commercial Distribution

  • 07332940001469 ()
900-0519

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

GeneXpert Dx System - 07332940001360

Additional catalog number: 900-0490R
CEPHEID
GXI-1
In Commercial Distribution

  • 07332940001360 ()
900-0490

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

UbiqVue Multiparameter - B353UB25501

2A Wearable Biosensor
Lifesignals, Inc.
UB2550
In Commercial Distribution

  • B353UB25502 ()
  • B353UB25501 ()
  • B353UB25503 ()


  • Wearable multiple physiological parameter recorder, single-use

UbiqVue Multiparameter - B353UB15501

1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, single-use

MonitorMe - B353MM12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system

MAWI - B353MA12511

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MA1251
Not in Commercial Distribution

  • B353MA12512 ()
  • B353MA12511 ()
  • B353MA12513 ()
MA1251_US

  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12531

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1253
In Commercial Distribution

  • B353LP12532 ()
  • B353LP12531 ()
  • B353LP12533 ()
LP1253_US

  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
LP1251
In Commercial Distribution

  • B353LP12511 ()
LP1251_US

  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder

CorVitals - B353CV12531

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
CV1253
In Commercial Distribution

  • B353CV12532 ()
  • B353CV12531 ()
  • B353CV12533 ()
CV1253_US

  • Electrocardiography telemetric monitoring system

CORVITALS - B353CV12451

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution

  • B353CV12452 ()
  • B353CV12451 ()
  • B353CV12453 ()


  • Electrocardiography telemetric monitoring system

Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder

MS X-RAY GRID - 04589744212284

237x290.5mm, 15:1, 100cm, 80L/cm, Material Number: 11514199
MITAYA MANUFACTURING CO., LTD.
GMS4K15100080S0001
In Commercial Distribution

  • 04589744212284 ()


  • Stationary x-ray grid

Medetz Surgical Instruments - G22312643530

Chang Nucleus Hydrodissector cannula 27 gauge 1.5mm flat standard tip angled 90 degree with beveled opening
Medetz Surgical Instruments LLC
12-64353
In Commercial Distribution

  • G22312643530 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MSI Precision Specialty Instruments - 00194613097455

Chang Hydrodissection Cannula 27 Gauge Flat Tip Angled 90° with beveled opening Long Tip Length 3.0mm
Med Saver, Inc.
11-8-6577
In Commercial Distribution

  • 00194613097455 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

CYBOW P - 08806141302094

The one device that has DI number included 100 strips
DFI CO.,LTD
0144
In Commercial Distribution

  • 08806141302094 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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