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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 - 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

Smart-V-Link - 00894912002777

Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software

SEDECAL - 08436046001862

This is a portable digital diagnostic x-ray system Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSLW4
In Commercial Distribution

  • 08436046001862 ()


  • Portable basic diagnostic x-ray system, digital
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