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The INVU by Nuvo™ System is a safe, non-invasive wearable monitoring system that provides continuous passive monitoring of vital pregnancy data of the pregnant person and the fetus through the INVU™ App. The information it provides is: Fetal heart rate (FHR), Maternal heart rate (MHR), and Uterine Activity (UA).
The INVU by Nuvo™ System (as a part of the INVU 3200 Family/Catalogue) includes a wearable sensory band NV-BTSH-3000 (INVU Sensor Band™) that connects wirelessly to the INVU™ App installed on the pregnant person’s mobile device. The system may include additional peripheral devices, such as a blood pressure measuring device, depending on the care plan prescribed by the pregnant person’s medical supervisor. The INVU™ App installed on the pregnant person’s smartphone can log the measured blood pressure. The monitored pregnancy data is displayed on the mobile device by the INVU™ App. The recorded monitored pregnancy data can also be viewed by an assigned medical supervisor (or by a remote monitoring medical service), using the INVU Pro™ web application.
Nuvo Group Usa, Inc.
NV-INVU-0001
In Commercial Distribution
- 07290018250044 ()
INVU 3200
- Foetal/maternal prenatal monitor
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h5 TiN
Not in Commercial Distribution
- D821003NAC395R0 ()
- Dental implant suprastructure, permanent, preformed
DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. Retentive caps, metal housing for the caps, directional rings and protective disc.
RHEIN 83 SRL
S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h5 TiN
003NAC395R
- Dental implant suprastructure, permanent, preformed
Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT2S
In Commercial Distribution
- 00851362008551 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT1R
In Commercial Distribution
- 00851362008452 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT2R
In Commercial Distribution
- 00851362008353 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT1S
In Commercial Distribution
- 00851362008346 ()
- Air-conduction hearing aid, behind-the-ear
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003027 ()
- Length: 30 Millimeter
- Length: 35 Millimeter
- Length: 40 Millimeter
- Length: 45 Millimeter
- Length: 50 Millimeter
- Length: 55 Millimeter
- Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511
- Intraurethral valve/pump
106900 Connex Server Application Software – Includes 2 thumb drives, one Production, one Test, with included software app, installer and Proview – Includes one ADT <(>&<)> one ORU production license, one ADT <(>&<)> one ORU test license – Includes 5 connectivity device test licenses – Includes Connex CS 1.8x DFU
WELCH ALLYN, INC.
901066
In Commercial Distribution
- 00732094244298 ()
106900
- Centralized patient monitor
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.
Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card.
ASCENSIA DIABETES CARE US INC.
7818
Not in Commercial Distribution
- 00301937818011 ()
- 0193-7818-01 ()
- 40301937818019 ()
85012037
- Glucose monitoring system IVD, home-use