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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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The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013406 ()
1151300010

  • Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013383 ()
1151306010

  • Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013376 ()
1151303010

  • Medical equipment clinical data interfacing software
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Moon Surgical Inc
100
In Commercial Distribution

  • 03770025849096 ()


  • Surgical camera holder
No Description
MILVUE
V2.x.x
In Commercial Distribution

  • 03770024774016 ()


  • X-ray image interpretive software
The Spectrum IQ Infusion System with Dose IQ Safety Software is an infusion pump that provides delivery of fluids into a patient in a controlled manner. The pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The Spectrum IQ infusion pump is specifically manufactured and calibrated for use with Baxter administration sets.
BAXTER INTERNATIONAL INC.
3570009
In Commercial Distribution

  • 00085412610900 ()
3570009

  • Bedside infusion pump, single-channel
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution

  • B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution

  • B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution

  • B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
WellSky Transfusion 2024 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2024 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT 128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional) WellSky Transfusion 2024 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2024
In Commercial Distribution

  • B105TRANSFUSION20240 ()


  • Blood bank information system application software
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