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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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ZepHr® pH Recorder
DIVERSATEK HEALTHCARE, INC.
Z07-2000-B-A
In Commercial Distribution

  • 00816734022160 ()
  • B019Z072000BA0 ()
Z07-2000-B-A

  • Manometric gastrointestinal motility analysis system
InSIGHT Ultima® Manometry System
DIVERSATEK HEALTHCARE, INC.
ULTSYS
In Commercial Distribution

  • 00816734022153 ()
  • B019ULTSYS0 ()
ULTSYS

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® Manometry System
DIVERSATEK HEALTHCARE, INC.
ULTCART
In Commercial Distribution

  • 00816734022146 ()
  • B019ULTCART0 ()
ULTCART

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

  • 00816734022139 ()
  • B019S9819257P10 ()
S98-1925-7P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-6P1
In Commercial Distribution

  • 00816734022122 ()
  • B019S9819256P10 ()
S98-1925-6P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-5P1
In Commercial Distribution

  • 00816734022115 ()
  • B019S9819255P10 ()
S98-1925-5P1

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
PHNS-P
In Commercial Distribution

  • 00816734022108 ()
  • B019PHNSP0 ()

  • Catheter Gauge: 5 French
PHNS-P

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
PHNS
In Commercial Distribution

  • 00816734022092 ()
  • B019PHNS0 ()

  • Catheter Gauge: 6.4 French
PHNS

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) with LES Port
DIVERSATEK HEALTHCARE, INC.
PHN5
In Commercial Distribution

  • 00816734022085 ()
  • B019PHN50 ()

  • Catheter Gauge: 6.4 French
PHN5

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 21cm Spacing
DIVERSATEK HEALTHCARE, INC.
PHN21
In Commercial Distribution

  • 00816734022078 ()
  • B019PHN210 ()

  • Catheter Gauge: 6.4 French
PHN21

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 15cm Spacing
DIVERSATEK HEALTHCARE, INC.
PHN15
In Commercial Distribution

  • 00816734022061 ()
  • B019PHN150 ()

  • Catheter Gauge: 6.4 French
PHN15

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
DIVERSATEK HEALTHCARE, INC.
PHN10-P
In Commercial Distribution

  • 00816734022054 ()
  • B019PHN10P0 ()

  • Catheter Gauge: 5 French
PHN10-P

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
DIVERSATEK HEALTHCARE, INC.
PHN10
In Commercial Distribution

  • 00816734022047 ()
  • B019PHN100 ()

  • Catheter Gauge: 6.4 French
PHN10

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Infused, Single pH (Esophageal) with LES Port
DIVERSATEK HEALTHCARE, INC.
PHIS
In Commercial Distribution

  • 00816734022030 ()
  • B019PHIS0 ()

  • Catheter Gauge: 6.9 French
PHIS

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Infused, Dual pH (Esophageal) 15cm Spacing with LES Port
DIVERSATEK HEALTHCARE, INC.
PHI15
In Commercial Distribution

  • 00816734022016 ()
  • B019PHI150 ()

  • Catheter Gauge: 6.9 French
PHI15

  • Manometric gastrointestinal motility analysis system
pH Calibration Buffer Tube
DIVERSATEK HEALTHCARE, INC.
L89-6021-40
In Commercial Distribution

  • 00816734021989 ()
  • B019L896021400 ()
L89-6021-40

  • Manometric gastrointestinal motility analysis system
inSIGHT Legacy Adaptor
DIVERSATEK HEALTHCARE, INC.
H12R-4500
In Commercial Distribution

  • 00816734021965 ()
  • B019H12R45000 ()
H12R-4500

  • Manometric gastrointestinal motility analysis system
Caring Mill Light Therapy Cleansing Brush
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
CM-HD-05-I
In Commercial Distribution

  • 00810025928476 ()


  • Red/blue light phototherapy unit
Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Special edition for TASHIO
NORAV MEDICAL LTD.
NR1207-3 Kit
In Commercial Distribution

  • 07290110255213 ()
NR12073-K-00-E-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Special edition for TASHIO
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110255206 ()
NR1207E-K-00-E-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110254889) for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors. Input cable with 5 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR1207-3 Kit
In Commercial Distribution

  • 07290110254919 ()
NR12073-K-00-UB10S5-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors. Input cable with 5 Patient leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
NR1207-3 Kit
In Commercial Distribution

  • 07290110254902 ()
NR12073-K-00-EB10S5-02

  • Electrocardiographic ambulatory recorder
Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling.
NORAV MEDICAL LTD.
NR1207-3
In Commercial Distribution

  • 07290110254896 ()
NR12073-D-00U-02

  • Electrocardiographic ambulatory recorder
Norav Wireless 3In1 Acquisition Device NR1 for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling.
NORAV MEDICAL LTD.
NR1207-3
In Commercial Distribution

  • 07290110254889 ()
NR12073-D-00U-01

  • Electrocardiographic ambulatory recorder
Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.
NORAV MEDICAL LTD.
NR1207-3
In Commercial Distribution

  • 07290110254872 ()
NR12073-D-00E-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254773) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254834 ()
NR1207E-K-00-U-B10-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110254766) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254827 ()
NR1207E-K-00-U-B10-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254810 ()
NR1207E-K-00-E-S10-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254759) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254780 ()
NR1207E-K-00-E-B10-02

  • Electrocardiographic ambulatory recorder
Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with AHA type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110254773 ()
NR1207E-D-00U-02

  • Electrocardiographic ambulatory recorder
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