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The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution
- 00817491023490 ()
FG-5902-01-300
- Implantable glucose monitoring system
For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is:
1 electrostimulator SPM01M1 configuration;
electrodes;
protective skin, and
1 tablet with the MySPM@Home mobile application (SPM01A2).
NCS LAB SRL
SPM01K4
In Commercial Distribution
- 08051122040971 ()
SPM01K4
- Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution
- 00884838103399 ()
- Extracorporeal ultrasound imaging transducer, hand-held
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution
- 06924274950608 ()
- Open-surgery electrosurgical electrode, monopolar, single-use
HD Rapid Simplified / 07 150grhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Vertex-Dental B.V.
HDARSP0700150
Not in Commercial Distribution
- 08719425505121 ()
- Dental appliance fabrication material, resin
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution
- 08052990321759 ()
- Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
mSpirometer
In Commercial Distribution
- 08052990321636 ()
- Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution
- 08052990321124 ()
911105
- Expiratory peak flow meter, digital
GAS-ASSISTED SPRAY SET ENDOSCOPIC APP. 5MM 30 CM, 1:1 RATIO
Micromedics, Inc.
SA-3654
In Commercial Distribution
- 10815634020075 ()
- 00815634020078 ()
- 20815634020072 ()
- Open-surgery adhesive/sealant applicator, dual-channel
Gastric Bypass Pack _Sterile_3EA/CShttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
GRI Medical & Electronic Technology Co., Ltd.
LGH011
In Commercial Distribution
- 26931918174539 ()
- 16931918174532 ()
- General surgical procedure kit, non-medicated, single-use