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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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Captus 4000e Thyroid Uptake System - 00859942006096

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System
In Commercial Distribution

  • 00859942006096 ()
5430-30151

  • Thyroid-uptake nuclear medicine system

ATOMLAB - 00718175000137

Thyroid Uptake System, Well Counter
BIODEX MEDICAL SYSTEMS, INC.
187-602
In Commercial Distribution

  • 00718175000137 ()
187-602

  • Thyroid-uptake nuclear medicine system

ATOMLAB - 00718175000021

Thyroid Uptake System, AtomLab 960, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-601
In Commercial Distribution

  • 00718175000021 ()
187-601

  • Thyroid-uptake nuclear medicine system

ATOMLAB - 00718175000014

Thyroid Uptake System, AtomLab 960, 120 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-600
In Commercial Distribution

  • 00718175000014 ()
187-600

  • Thyroid-uptake nuclear medicine system

Fever Garde - 08800132200413

The Bluetooth Wearable Thermometer is an electronic thermometer using a sensor to measure right armpit temperature. Its operation is based on measuring the natural thermal radiation emanating from the armpit and the adjacent surfaces. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device. Purpose of measuring body temperature is to check body condition by measuring correct temperature in important part of body and both measured room temperature and relative humidity are to show environmental conditions. In case of right armpit measurement, this product searches the highest temperature from the right armpit.
HuBDIC Co., Ltd.
HMT-100
In Commercial Distribution

  • 08800132200413 ()


  • Wireless patient thermometer, reusable

4D View - 00840682102780

No Description
GE Healthcare Austria GmbH & Co OG
16
In Commercial Distribution

  • 00840682102780 ()


  • Ultrasound imaging system operation software

4D View - 00840682137621

No Description
GE Healthcare Austria GmbH & Co OG
18
In Commercial Distribution

  • 00840682137621 ()


  • Ultrasound imaging system operation software

4D View - 00840682122788

No Description
GE Healthcare Austria GmbH & Co OG
17
In Commercial Distribution

  • 00840682122788 ()


  • Ultrasound imaging system operation software

Critical Care Suite - 00840682146340

No Description
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00840682146340 ()


  • X-ray image interpretive software

Rayvolve - 03770018071084

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over).
AZMED
4
In Commercial Distribution

  • 03770018071084 ()


  • X-ray image interpretive software
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