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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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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
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