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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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ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; Signal Averaged ECG (SAECG); WAM Wireless Acquisition Mo
WELCH ALLYN, INC.
901133
In Commercial Distribution

  • 00732094265217 ()
ELI380-DCT12

  • Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; WAM Wireless Acquisition Module; IEC 10 wire, 12- lead l
WELCH ALLYN, INC.
901133
In Commercial Distribution

  • 00732094265200 ()
ELI380-DCX12

  • Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; AM12 Wired Acquisition Module; IEC 10 wire, 12- lead lea
WELCH ALLYN, INC.
901133
In Commercial Distribution

  • 00732094265194 ()
ELI380-DCX22

  • Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; AM12 Wired Acquisition Module (for use with Quickels Dec
WELCH ALLYN, INC.
901133
In Commercial Distribution

  • 00732094265187 ()
ELI380-DCX32

  • Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; AM15E patient cable; IEC 13 wire, 15-lead lead set with
WELCH ALLYN, INC.
901133
In Commercial Distribution

  • 00732094265170 ()
ELI380-DCX44

  • Electrocardiograph, professional, multichannel
No Description
STARKEY LABORATORIES, INC.
PRO AKUSTIK IPRO T.6 AI RIC R (Right)
In Commercial Distribution

  • 00842318179159 ()
63199-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
PRO AKUSTIK IPRO T.5 AI RIC R (Right)
In Commercial Distribution

  • 00842318179142 ()
63105-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
(DEMO) AUDIOSYNC ARC AI 2400 BTE 13 POWER PLUS
In Commercial Distribution

  • 00842318189882 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
STARKEY LABORATORIES, INC.
(DEMO) MICROTECH ENVY AI 2400 BTE 13 POWER PLUS
In Commercial Distribution

  • 00842318189875 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
(DEMO) NUEAR SAVANT AI 2400 BTE 13 POWER PLUS
In Commercial Distribution

  • 00842318189868 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
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