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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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HScribe - 00817655022260

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBWS-6AC-DXXXX
In Commercial Distribution

  • 00817655022260 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655022239

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-AXXXA
In Commercial Distribution

  • 00817655022239 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655022161

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-YXXXB
In Commercial Distribution

  • 00817655022161 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021904

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSERV-6BA-XXXXA
In Commercial Distribution

  • 00817655021904 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021829

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-YXXXA
In Commercial Distribution

  • 00817655021829 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021744

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-AXXXB
In Commercial Distribution

  • 00817655021744 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021461

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-EYA-BXXXX
Not in Commercial Distribution

  • 00817655021461 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021102

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AA-AAXXA
Not in Commercial Distribution

  • 00817655021102 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021096

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AB-AXXXC
Not in Commercial Distribution

  • 00817655021096 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021089

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AB-AXXXB
Not in Commercial Distribution

  • 00817655021089 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021072

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AB-AXXXA
Not in Commercial Distribution

  • 00817655021072 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00817655020860

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00817655020860 ()
HSCRIBE-6AA-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094281330

SOFTWARE HSCRIBE v6.2.0
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094281330 ()
11110-003-50

  • Electrocardiographic long-term ambulatory recording analyser application software

Pathway® - 00852423006394

Pathway® NMR 200 Dual Channel Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
NMR 200
In Commercial Distribution

  • 00852423006394 ()
NMR 200

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006073

Pathway® MR-10 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-10
In Commercial Distribution

  • 00852423006073 ()
9700

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006066

Pathway® MR-15 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-15
In Commercial Distribution

  • 00852423006066 ()
9715

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006059

Pathway® MR-20 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-20
In Commercial Distribution

  • 00852423006059 ()
9710

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006042

Pathway® MR-25 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-25
In Commercial Distribution

  • 00852423006042 ()
9725

  • Perineometer
  • Psychophysiological biofeedback system

Stethee Pro Central Web Application - 09351356000055

Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000055 ()


  • Phonocardiograph
  • Stethoscope application software

Stethee Pro Mobile iOS Application - 09351356000048

Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software

Stethee Pro Mobile Android Application - 09351356000031

Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software

BioSerenity-Link - 03615220003785

BioSerenity-Link is a mobile application capable of sharing phone connectivity, recording video and uploading it to the BioSerenity Cloud
BIOSERENITY MEDICAL DEVICES GROUP
5100-00021-UN
Not in Commercial Distribution

  • 03615220003785 ()


  • Camera application software
  • Medical networking interface unit

Spacelabs - 10841522108792

OPTION, SPACELABS SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
Not in Commercial Distribution

  • 10841522108792 ()
R-91496-U

  • Patient monitoring system module, multifunction

Spacelabs - 10841522108785

OPTION, NELLCOR OXIMAX SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
Not in Commercial Distribution

  • 10841522108785 ()
R-91496-N

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522108778

OPTION, MASIMO SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522108778 ()
R-91496-M

  • Patient monitoring system module, multifunction

Ultraview SL - 10841522106439

OPTION,SPACELABS SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultraview SL®
In Commercial Distribution

  • 10841522106439 ()
91496-U

  • Patient monitoring system module, multifunction

Ultraview SL - 10841522106422

OPTION,NELLCOR OXIMAX SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultraview SL®
In Commercial Distribution

  • 10841522106422 ()
91496-N

  • Patient monitoring system module, multifunction

Ultraview SL - 10841522106415

OPTION, MASIMO SET SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
In Commercial Distribution

  • 10841522106415 ()
91496-M

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522107788

91496 UVSL COMMAND MODULE - NELLCOR
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522107788 ()
L-91496-N

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522107771

91496 UVSL COMMAND MODULE - MASIMO
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522107771 ()
L-91496-M

  • Patient monitoring system module, multifunction

Soan - 03760349805335

1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)
DENTALHITEC
SOAN1
In Commercial Distribution

  • 03760349809951 ()
  • 03760349805335 ()
SOAN1

  • Dental computer assisted anaesthesia injection unit
  • Dental syringe needle, single-use

StethoAI Digital Stethoscope - 00860011532804

A high-quality digital stethoscope that connects directly to the 3.5mm jack of your computer or your mobile phone.
Stethoai LLC
1
In Commercial Distribution

  • 00860011532804 ()
1

  • Electronic acoustic stethoscope

Codonics Safe Label System®(SLS) 550i Point of Care Station - 00814905020366

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
CODONICS INC.
550i PCS
In Commercial Distribution

  • 00814905020366 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020250

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-142C
CODONICS INC.
500i PCS -142C
In Commercial Distribution

  • 00814905020250 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020243

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-141C
CODONICS INC.
500i PCS -141C
In Commercial Distribution

  • 00814905020243 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020236

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-140C
CODONICS INC.
500i PCS -140C
In Commercial Distribution

  • 00814905020236 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020229

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
CODONICS INC.
500i PCS
In Commercial Distribution

  • 00814905020229 ()


  • Parenteral-nutrition management software

CareLink Encore™ - 00643169369030

PROGRAMMER 29901 CARELINK ENCORE US
MEDTRONIC, INC.
29901
Not in Commercial Distribution

  • 00643169369030 ()


  • Cardiac pulse generator programmer

Nonin - 00849686088151

7600PA Sensor Lock
NONIN MEDICAL, INC.
7600PA Sensor Lock
In Commercial Distribution

  • 00849686088151 ()


  • Sensor holder, reusable

Nonin - 00849686086188

7600PA Sensor Lock
NONIN MEDICAL, INC.
7600PA INT C Lock
In Commercial Distribution

  • 00849686086188 ()


  • Sensor holder, reusable

RECEIVER DISH STAND - 04953170305771

MAJ-1907 ScopeGuide Receiver Dish Stand
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1907
In Commercial Distribution

  • 04953170305771 ()
N3807000

  • Sensor holder, reusable

ANTENNA UNIT HOLDER - 04953170333330

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2034
In Commercial Distribution

  • 04953170333330 ()
N4472130

  • Sensor holder, reusable

RECEIVER DISH STAND SUPPLEMENTARY SET - 04953170305887

MAJ-1978 ScopeGuide RD Stand SET
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1978
Not in Commercial Distribution

  • 04953170305887 ()


  • Sensor holder, reusable

RECEIVER DISH ARM - 04953170305856

MAJ-1962 MAJ-1692 ScopeGuide Receiver Di
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1962
In Commercial Distribution

  • 04953170305856 ()


  • Sensor holder, reusable

HOLDER FOR HC-RP - 04953170305849

MAJ-1938 ScopeGuide Holder for HC-RC
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1938
In Commercial Distribution

  • 04953170305849 ()
  • 84953170305845 ()
N3807700

  • Sensor holder, reusable

Reference Plate Cover - 04953170077746

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-996
Not in Commercial Distribution

  • 04953170077746 ()


  • Sensor holder, reusable

CareLink Encore™ - 00613994909688

PROGRAMMER 29901 CARELINK ENCORE US
MEDTRONIC, INC.
29901
Not in Commercial Distribution

  • 00613994909688 ()


  • Cardiac pulse generator programmer

CareLink Encore™ - 00613994909565

PROGR HEAD 26901 ENCORE
MEDTRONIC, INC.
26901
In Commercial Distribution

  • 00613994909565 ()


  • Cardiac pulse generator programmer

SJM™ - 05414734501668

Telemetry Wand
ST. JUDE MEDICAL, INC.
3630
In Commercial Distribution

  • 05414734501668 ()
3630

  • Cardiac pulse generator programmer

NA - 00681490207256

SFTWR 9766A 3MM CUT BURR 70MM 5/BX
MEDTRONIC, INC.
9766A
Not in Commercial Distribution

  • 00681490207256 ()


  • Cardiac pulse generator programmer
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