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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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Engage Medical Device Alarm Notification System (EMDAN) - 00860002177700

No Description
STRYKER CORPORATION
EMDAN 2.1.0
In Commercial Distribution

  • 00860002177700 ()
910-01953

  • Alarm application software

Pulsaderm - 00858830007764

Blue LED Light for the treatment of acne
PULSADERM LLC
PD9700R
In Commercial Distribution

  • 00858830007764 ()


  • Red/blue light phototherapy unit

LED Blue Acne Clearing Mask - 00858830007047

Blue LED Light for the treatment of acne
PULSADERM LLC
PD9700
In Commercial Distribution

  • 00858830007047 ()


  • Red/blue light phototherapy unit

myPatch® - 00857522005019

3 channel Holter recorder
DMS-SERVICE LLC
s
In Commercial Distribution

  • 00857522005019 ()

  • Length: 40 Millimeter
  • Depth: 10 Millimeter
  • Width: 49 Millimeter
mp3

  • Electrocardiographic ambulatory recorder

VMA Motion Normalizer - 00868579000247

VMA Motion Normalizer (Console, Table, and Upright assemblies)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000247 ()


  • Diagnostic x-ray digital imaging system workstation

VMA - 00868579000209

No Description
ORTHO KINEMATICS, INC.
2
In Commercial Distribution

  • 00868579000209 ()


  • Diagnostic x-ray digital imaging system workstation

Zio monitor - 00869770000241

No Description
IRHYTHM TECHNOLOGIES, INC.
DFG0001
In Commercial Distribution

  • 00869770000241 ()


  • Electrocardiographic ambulatory recorder

ZIO SR Patch - 00869770000234

ZIO SR ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
K100A101X
Not in Commercial Distribution

  • 00869770000234 ()


  • Electrocardiographic ambulatory recorder

ZIO AT Patch - 00869770000210

ZIO AT ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
A100A100X
In Commercial Distribution

  • 00869770000210 ()


  • Electrocardiographic ambulatory recorder

ZIO XT Patch - 00869770000203

ZIO XT ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
N100A102X
In Commercial Distribution

  • 00869770000203 ()


  • Electrocardiographic ambulatory recorder

100mm x 22m ECG Printer Paper (2/roll) - 00681490597722

PAPER ROLLS, 100MM WIDE,ECG
PHYSIO-CONTROL, INC.
11240
Not in Commercial Distribution

  • 00681490597722 ()
11240-000016

  • Patient monitoring system module, printing

50mm x 22m ECG Printer Paper (3/roll) - 00681490595896

PAPER-ELECTROCARDIOGRAM,RECORDING
PHYSIO-CONTROL, INC.
11240
In Commercial Distribution

  • 00681490595896 ()
11240-000013

  • Patient monitoring system module, printing

DelWorks - 00858340006097

PORTABLE WORKSTATION Wirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistance The DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.
Del Medical, Inc.
3.0
In Commercial Distribution

  • 00858340006097 ()


  • Diagnostic x-ray digital imaging system workstation

CONTEC - 06945040101406

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC6000
In Commercial Distribution

  • 06945040101406 ()


  • Electrocardiographic ambulatory recorder

CONTEC - 06945040100294

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5000
In Commercial Distribution

  • 06945040100294 ()


  • Electrocardiographic ambulatory recorder

CONTEC - 06945040101499

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5007
In Commercial Distribution

  • 06945040101499 ()


  • Electrocardiographic ambulatory recorder

ORLocate - 00724995243692

Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
STERIS CORPORATION
ORLocate Tablet
In Commercial Distribution

OX216

  • Electronic surgical sponge-counter

Welch Allyn, Inc. - 00732094334944

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094334944 ()
RSCRIBE-6CC-AXDBA

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328851

H12+ Standard 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328851 ()
H12PLUS-LPC-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327779

H12+ High Fidelity 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends;
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094327779 ()
H12PLUS-NPA-XXXXX

  • Electrocardiographic ambulatory recorder
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