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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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Lutech - B299750MIC0

Multi-parameter patient monitor. 750-M-IC
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MIC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750MI0

Multi-parameter patient monitor. 750-M-I
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MI0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750MCP0

Multi-parameter patient monitor. 750-M-C-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MCP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750MC0

Multi-parameter patient monitor. 750-M-C
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750M0

Multi-parameter patient monitor. 750-M
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750M0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LP0

Multi-parameter patient monitor. 750-L-P.
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LIP0

Multi-parameter patient monitor. 750-L-I-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LIP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LICP0

Multi-parameter patient monitor. 750-L-IC-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LICP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LIC0

Multi-parameter patient monitor. 750-L-IC
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LIC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LI0

Multi-parameter patient monitor. 750-L-I
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LI0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LCP0

Multi-parameter patient monitor. 750-L-C-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LCP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LC0

Multi-parameter patient monitor. 750-L-C
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750L0

Multi-parameter patient monitor. 750-L
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750L0 ()


  • Multiple vital physiological parameter monitoring system, clinical

WVSM Wireless Vital Signs Monitor - B3945000034040

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034040 ()
500-0034-04

  • Multiple vital physiological parameter monitoring system, clinical

WVSM Wireless Vital Signs Monitor - B3945000034030

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034030 ()
500-0034-03

  • Multiple vital physiological parameter monitoring system, clinical

WVSM Wireless Vital Signs Monitor - B3945000034020

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034020 ()
500-0034-02

  • Multiple vital physiological parameter monitoring system, clinical

WVSM Wireless Vital Signs Monitor - B3945000034010

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034010 ()
500-0034-01

  • Multiple vital physiological parameter monitoring system, clinical

Athena GTX Device Management Suite (ADMS) Software - B3943950010000

Athena GTX Device Management Suite - Android
ATHENA GTX, INC.
ADMS Android Software
In Commercial Distribution

  • B3943950010000 ()
395-0010-00

  • Centralized patient monitor

Athena GTX Device Management Suite (ADMS) Software - B3943950009000

Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor

WVSM Wireless Vital Signs Monitor - B3943950006000

WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor

Athena GTX Device Management Suite (ADMS) Software - B3943900008000

Athena GTX Device Management Suite - PC
ATHENA GTX, INC.
ADMS PC Software
In Commercial Distribution

  • B3943900008000 ()
390-0008-00

  • Centralized patient monitor

WVSM Wireless Vital Signs Monitor - B3943900004000

WVSM Management Suite - PC
ATHENA GTX, INC.
PC Software
In Commercial Distribution

  • B3943900004000 ()
390-0004-00

  • Centralized patient monitor

EyeSuite Software - 07640132986105

No Description
Haag-Streit AG
i8.2
In Commercial Distribution

  • 07640132986105 ()


  • Medical image management system

Arthrex® - 00888867387928

BioOptico Spectral Mode Key Kit
ARTHREX, INC.
AR-3200-1026
In Commercial Distribution

  • 00888867387928 ()
AR-3200-1026

  • Medical image management system

EyeSuite Software - 07640132987256

No Description
Haag-Streit AG
i9.0
In Commercial Distribution

  • 07640132987256 ()


  • Medical image management system

Criticare - B438560DNUS0

Monitor with DOX SPO2, NIBP, and HR
CRITICARE TECHNOLOGIES, INC.
eQuality 506DN
In Commercial Distribution

  • B438560DNUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506LNVP30

Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNVP3
In Commercial Distribution

  • B438506LNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506LNP30

Monitor with Nellcor SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNP3
In Commercial Distribution

  • B438506LNP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506DNVP30

Monitor with DOX SPO2, NIBP, HR, Printer and Temp
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNVP3
In Commercial Distribution

  • B438506DNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506DNP3US0

Monitor with DOX SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNP3
In Commercial Distribution

  • B438506DNP3US0 ()


  • Multiple vital physiological parameter monitoring system, clinical

BCI - 10610586036347

No Description
ICU MEDICAL, INC.
3304
In Commercial Distribution

  • 10610586036347 ()


  • Multiple vital physiological parameter monitoring system, clinical

Amimon - 00817157020825

No Description
AMIMON LTD
MD52 Rx - MDWL2_B3P1RX
In Commercial Distribution

  • 00817157020825 ()


  • Medical image management system

Amimon - 00817157020818

No Description
AMIMON LTD
MD52 Tx - MDWL2_B1P1TX
In Commercial Distribution

  • 00817157020818 ()


  • Medical image management system

Amimon - 00817157020771

No Description
AMIMON LTD
MD11 System - MDWL1_B1N1RX
In Commercial Distribution

  • 00817157020771 ()


  • Medical image management system

Amimon - 00817157020764

No Description
AMIMON LTD
MD11 System - MDWL1_C1N1TX
In Commercial Distribution

  • 00817157020764 ()


  • Medical image management system

Amimon - 00817157020757

No Description
AMIMON LTD
MD62 System - MDWL2_B1J1RX
In Commercial Distribution

  • 00817157020757 ()


  • Medical image management system

Amimon - 00817157020740

No Description
AMIMON LTD
MD62 System - MDWL2_B1J1TX
In Commercial Distribution

  • 00817157020740 ()


  • Medical image management system

Portable X-Ray System - 00817100020353

Portable X-Ray System-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR301
In Commercial Distribution

  • 00817100020353 ()


  • Portable basic diagnostic x-ray system, digital

Portable X-Ray System - 00817100020124

SR-130 + DR Portable VIZION M portavle X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR310
In Commercial Distribution

  • 00817100020124 ()


  • Portable basic diagnostic x-ray system, digital

Portable X-Ray System - 00817100020117

SR-130 + DR Portable X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR300
In Commercial Distribution

  • 00817100020117 ()


  • Portable basic diagnostic x-ray system, digital

Arthrex® - 00888867226975

Synergy.Net HL7 Software Single License
ARTHREX, INC.
AR-3200-1047
In Commercial Distribution

  • 00888867226975 ()
AR-3200-1047

  • Medical image management system

Arthrex® - 00888867100619

SYNERGYHD3 DICOM KEY
ARTHREX, INC.
AR-3200-1020
In Commercial Distribution

  • 00888867100619 ()
AR-3200-1020

  • Medical image management system

Arthrex® - 00888867261648

Synergy Matrix Management SW Addtnl Lic
ARTHREX, INC.
AR-3200-1049
In Commercial Distribution

  • 00888867261648 ()
AR-3200-1049

  • Medical image management system

Arthrex® - 00888867200319

Synergy.Net Text Notification License K
ARTHREX, INC.
AR-3200-1046
In Commercial Distribution

  • 00888867200319 ()
AR-3200-1046

  • Medical image management system

Arthrex® - 00888867200296

Synergy.Net OR Command License Key
ARTHREX, INC.
AR-3200-1044
In Commercial Distribution

  • 00888867200296 ()
AR-3200-1044

  • Medical image management system

Arthrex® - 00888867200302

Synergy.Net Reporting License Key
ARTHREX, INC.
AR-3200-1045
In Commercial Distribution

  • 00888867200302 ()
AR-3200-1045

  • Medical image management system

Arthrex® - 00888867200289

Synergy.net Printing License Key
ARTHREX, INC.
AR-3200-1043
In Commercial Distribution

  • 00888867200289 ()
AR-3200-1043

  • Medical image management system

Sun Nuclear Phototimer Consistency Tools - B136159ABR0

No Description
SUN NUCLEAR CORP.
159ABR
In Commercial Distribution

  • B136159ABR0 ()


  • Mammographic x-ray phantom, test object

Phototimer Consistency Tools - B136159A0

No Description
SUN NUCLEAR CORP.
159A
In Commercial Distribution

  • B136159A0 ()


  • Mammographic x-ray phantom, test object

Sun Nuclear Mammo 156D Stereo Phantom - B136156D0

No Description
SUN NUCLEAR CORP.
156D
In Commercial Distribution

  • B136156D0 ()


  • Mammographic x-ray phantom, test object
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