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The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included).
The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
COMPANION MEDICAL, INC.
Novo - Pink
In Commercial Distribution
- 62088-0000-36 ()
- 10862088000368 ()
InPen-100NN-PK / MMT-105NNPK
- Empty self-injector, mechanical
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included).
The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
COMPANION MEDICAL, INC.
Novo - Grey
In Commercial Distribution
- 62088-0000-35 ()
- 10862088000351 ()
InPen-100NN-GY / MMT-105NNGY
- Empty self-injector, mechanical
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included).
The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
COMPANION MEDICAL, INC.
Novo - Blue
In Commercial Distribution
- 62088-0000-34 ()
- 10862088000344 ()
InPen-100NN-BL / MMT-105NNBL
- Empty self-injector, mechanical
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included).
The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
COMPANION MEDICAL, INC.
Lilly - Pink
In Commercial Distribution
- 62088-0000-33 ()
- 10862088000337 ()
InPen-100EL-PK / MMT-105ELPK
- Empty self-injector, mechanical
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included).
The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
COMPANION MEDICAL, INC.
Lilly - Grey
In Commercial Distribution
- 62088-0000-32 ()
- 10862088000320 ()
InPen-100EL-GY / MMT-105ELGY
- Empty self-injector, mechanical
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included).
The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
COMPANION MEDICAL, INC.
Lilly - Blue
In Commercial Distribution
- 62088-0000-31 ()
- 10862088000313 ()
InPen-100EL-BL / MMT-105ELBL
- Empty self-injector, mechanical
The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment.
The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen.
In particular, the device is intended to provide:
Linear distance measurements of anatomical structures,
Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen,
Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies,
Measurement of brightness ratio between structures and in particular between the liver and the kidney,
Estimates of speed of sound in the liver.
The device is composed of:
- Hepatoscope App
- an external ultrasound E.C5-1 Probe(accessory) dedicated to abdominal imagingand liver imaging. The E.C5-1 Probe is a curvilinear low-frequency ultrasound imaging
probe that connects to the Laptop (SelectedHost) via a dedicated USB-C lead cable,consisting of an electrodynamic vibratorlocated at its back, which generates transient
vibrations.
E-SCOPICS
eC5-1 probe
In Commercial Distribution
- 03770023859004 ()
- Hand-held ultrasound imaging system, body-surface
- Hepatic ultrasound elastography system applicator
roclub TeleOperationPlatform (rTOP) is a medical device (including hardware and software) for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices.
rTOP provides a private, secure communication platform for real-time image visualization and cross-organizational collaboration between healthcare professionals across multiple sites. rTOP enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location.
rTOP is based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard.
The remote operator can establish connections to more than one rC. Additional remote operators can connect for assistance or training purposes. The connection is possible in full control or read-only mode. The access to the system must be granted by the local user using the system. The access to the system can be revoked at any time by the local user, thus allowing the local user full control of the session at all times.
The full-control accessibility to higher risk modalities with physical switches (CT scanners) is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation.
roclub GmbH
1
Not in Commercial Distribution
- 09120138870014 ()
-
- Radiology DICOM image processing application software
rebless™ (Model: RHBD) has been designed to provide a safe and efficient solution for individuals recovering after joint surgeries, injuries, neurological movement disorders improving range of motion, muscle strength, and enhancing overall physical performance. This device incorporates robotic and isokinetic technology, making it a versatile and essential tool for physical therapy clinics, sports medicine facilities, and home use.
rebless™ (Model: RHBD) is a robotic, exercise therapy device for both upper and lower limbs, providing motion to the elbow, wrist, ankle, and knee joints. With multiple operating modes, rebless™ allows for passive and active-assisted range of motion and resisted exercise, so therapy can be customized based on each individual patient’s condition and progress. rebless™ is controlled through an app downloaded onto the patient’s smartphone or mobile device.
rebless™ provides therapeutic treatment at home or in clinics for patients suffering from neurological or musculoskeletal conditions.
Key features:
1) Isokinetic:
The standout feature of rebless™ (Model: RHBD) device is its isokinetic functionality. Isokinetic exercise ensures that resistance remains constant throughout a range of motion, adapting to the user's force output. This capability is particularly valuable in rehab settings, allowing patients to exercise at a pace that suits their recovery and minimizing the risk of further injury.
2) Adjustable resistance:
The device provides a wide range of adjustable resistance settings, accommodating to apply resistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs.
3) Adjustable assistance:
The device provides a wide range of adjustable assistance settings, to apply assistance level based on
their abilities. This adaptability is crucial for progression in rehabilitation and training programs.
H ROBOTICS INC.
RHDB
In Commercial Distribution
- 08800101600183 ()
1
- Continuous passive motion joint exerciser
Device Description:
The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics
and home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device.
The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a
Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops
including inspiratory and expiratory data. The internal program performs all of the calculations for
measurements to meet American Thoracic Society and European Respiratory Society requirements. It has
built-in quality control measurements and transmits indices of measurement quality including time to peak
flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.
It is used with the GoSpiro App display and communications software on a smartphone or tablet.
The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging
station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC
60601-1-11.
The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer
measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus
avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the
device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This
transducer is insensitive to the effects of condensation and temperature and avoids the need for individual
calibration prior to performing a test.
Indications for Use:
The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics
and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.
MONITORED THERAPEUTICS, INC.
45-90058
In Commercial Distribution
- 00860000692809 ()
45-90058
- Diagnostic spirometer, professional