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DreamMapper iOS NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051331 ()
1101478
- Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049932 ()
1101478
- Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049086 ()
1101478
- Self-care monitoring/reporting software
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution
- 09321502078962 ()
P1646054
- Audiometric/hearing device software
Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution
- 09321502078955 ()
P1646035
- Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution
- 09321502053006 ()
P1646035
- Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution
- 09321502052993 ()
P1646054
- Audiometric/hearing device software
No Description
Brainlab AG
1.2
In Commercial Distribution
- 04056481145385 ()
- Multidisciplinary medical image management software
No Description
Brainlab AG
1.1
Not in Commercial Distribution
- 04056481144265 ()
- Multidisciplinary medical image management software
No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution
- 03701311501497 ()
- Robotic surgical navigation system application software
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is
intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution
- 00810038851983 ()
- Cardiopulmonary physiological parameter analysis software
Dream Sock Software App.
The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not
intended to provide notification for every episode of the unexpected occurrences of elevated or
depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only
when sufficient data are available for analysis. The notifications and associated data can be used to
supplement the decision by caregivers to seek additional guidance for medical care of the infant. The
Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution
- 00810099090819 ()
- Multiple vital physiological parameter monitoring system, home-use
An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
NEUROLIEF LTD
RLV-PMI-102
In Commercial Distribution
- 07290018393147 ()
- Configurable electronic form web-based application software
The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider.
The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan.
The Diary Mobile app is suited for both iPhone and Android users.
The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above
the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information.
The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.
DREAMED DIABETES LTD
02.XX.YY
In Commercial Distribution
- 07290017735030 ()
N/A
- Clinical management support software
A Windows based desktop widget application that can be connected to the laptop’s webcam, the Orpheus GATE or a USB connected camera.
It is useful also to drag images from a USB connected camera/smartphone or from the PC/Laptop directory and upload to the Orpheus System.
For example: discharge workflow in which clinicians record a video session with the patient explaining their care path and requirements after discharge.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution
- 07290017025094 ()
MAU-EG20004
- Radiology information system application software
No Description
Sonova AG
088-0021
In Commercial Distribution
- 07613389543254 ()
- Audiometric/hearing device software
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution
- 25060753520070 ()
- Video otoscope/audiometer
No Description
Thought Technology Ltd.
SA9030
In Commercial Distribution
- 07540191000586 ()
- Psychophysiological biofeedback system
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Perineal orifice incontinence-control electrical stimulation system probe, reusable
No Description
Thought Technology Ltd.
SA9013
In Commercial Distribution
- 07540191000548 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Psychophysiological biofeedback system
- Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Thought Technology Ltd.
SA4502
In Commercial Distribution
- 07540191000487 ()
- Psychophysiological biofeedback system
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution
- 15694311111665 ()
- Sleep disorder interpretive software, professional-only
Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873901
In Commercial Distribution
- 00842768018503 ()
- 00630414639741 ()
10873901
- Fibrinogen assay (factor I) IVD, reagent
Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873900
In Commercial Distribution
- 00842768018541 ()
- 00630414639734 ()
10873900
- Fibrinogen assay (factor I) IVD, reagent
No Description
TECHNO-PATH MANUFACTURING LIMITED
09339876190
In Commercial Distribution
- 05391523442060 ()
- Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
09339868190
In Commercial Distribution
- 05391523442053 ()
- Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
08P89-10
In Commercial Distribution
- 05391523440752 ()
- Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC202A.10
In Commercial Distribution
- 05391523440424 ()
- Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC201A.10
In Commercial Distribution
- 05391523440417 ()
- Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC202X
In Commercial Distribution
- 05391523440394 ()
- Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
05P80-10
In Commercial Distribution
- 05391523440073 ()
- Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC20BX
Not in Commercial Distribution
- 05391523440400 ()
- Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC201X
In Commercial Distribution
- 05391523440387 ()
- Multiple-type clinical chemistry analyte profile IVD, control
Universal sheath Omnitex U - green - nitrile
OMNIA SRL
30.Z0010.00
In Commercial Distribution
- 08056646506293 ()
- 08056646506286 ()
- Medical equipment/instrument drape, single-use
The medilog®AR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attachingelectrodes, etc.) is performed by the technician or doctor.
Schiller AG
1A.306010
In Commercial Distribution
- 07613365003765 ()
- 07613365003697 ()
1A.306010
- Electrocardiographic ambulatory recorder
Siren, 24V, UL Approved
Securitas Healthcare LLC
56108
In Commercial Distribution
- 00840948101137 ()
- Nurse call system alarm
Ethernet Switch, 48 Ports, PoE
Securitas Healthcare LLC
56106
In Commercial Distribution
- 00840948101090 ()
- Computer network router
Ethernet Switch, 24+2 Ports, PoE
Securitas Healthcare LLC
56105
In Commercial Distribution
- 00840948101083 ()
- Computer network router
Arial U Client PC
Securitas Healthcare LLC
56111
In Commercial Distribution
- 00840948101076 ()
- Desktop computer
Arial U Server PC
Securitas Healthcare LLC
56110
In Commercial Distribution
- 00840948101069 ()
- Network server
CORD, NURSE CALL, 15 FT
Securitas Healthcare LLC
56116
In Commercial Distribution
- 00840948101052 ()
- Length: 15 Feet
- Fixed call button
CORD, NURSE CALL, 7 FT
Securitas Healthcare LLC
56115
In Commercial Distribution
- 00840948101045 ()
- Length: 7 Feet
- Fixed call button
Code Call Station Kit
Securitas Healthcare LLC
CSK-1000-CD
In Commercial Distribution
- 00840948101038 ()
- Fixed call button
Arial U Software
Securitas Healthcare LLC
56112
In Commercial Distribution
- 00840948101021 ()
- Medical networking interface unit
GW-1000 Gateway
Securitas Healthcare LLC
GW-1000
In Commercial Distribution
- 00840948101014 ()
- Medical networking interface unit
Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
SONOSCANNER
PRO
In Commercial Distribution
- 03701104600291 ()
- General-purpose ultrasound imaging system
Dual-curing universal adhesive. DCA Dual cure activator.
VOCO GmbH
1578
In Commercial Distribution
- E22115781 ()
1578
- Dentine bonding agent/set
Dual-curing universal adhesive in 5ml bottles
VOCO GmbH
1577
In Commercial Distribution
- E22115771 ()
1577
- Dentine bonding agent/set
Dual-curing universal adhesive.
VOCO GmbH
1576
In Commercial Distribution
- E22115761 ()
1576
- Dentine bonding agent/set
Dual-curing universal adhesive.
VOCO GmbH
1574
In Commercial Distribution
- E22115741 ()
- E22115740 ()
1574
- Dentine bonding agent/set
Dual-curing universal adhesive.
VOCO GmbH
1572
In Commercial Distribution
- E22115721 ()
- E22115720 ()
1572
- Dentine bonding agent/set