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 SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.0SP03
In Commercial Distribution

  • 04250903201196 ()
2067634-055

  • Electrocardiographic ambulatory recorder
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
No Description
CURBELL MEDICAL PRODUCTS, INC.
Rego Safe Mobility App
In Commercial Distribution

  • 00840828192095 ()


  • Inpatient motion surveillance software
For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM mobile application (SPM01A1).
NCS LAB SRL
SPM01K3
In Commercial Distribution

  • 08051122040964 ()
SPM01K3

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120272 ()
18239

  • Ambulatory insulin infusion pump software, data-display
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution

  • 00817491023537 ()
FG-5502-02-300

  • Implantable glucose monitoring system
Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system
SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software
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