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No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution
- 00850011790007 ()
- MRI system application software
iLet Bionic Pancreas (Pharmacy Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution
- 00850050080206 ()
BB1004
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Government Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution
- 00850050080190 ()
BB1003
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Commercial Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution
- 00850050080183 ()
BB1002
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Commercial Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution
- 00850050080046 ()
BB1002
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Government Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution
- 00850050080039 ()
BB1003
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Pharmacy Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution
- 00850050080022 ()
BB1004
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications.
Healthcare professionals are the intended operators of this device.
The Device is intended for use on patients who are 18 years of age or older.
The Device is not intended for critical care.
BIOINTELLISENSE, INC.
SW-BDB
In Commercial Distribution
- 00850005949466 ()
N/A
- Clinical management support software
Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
SIRTEX MEDICAL PTY LTD
X-SMAC-01
In Commercial Distribution
- 00850014612108 ()
- Clinical management support software
CytoVision V7.6 configuration
Leica Biosystems Richmond, Inc.
23SWR00076CV
Not in Commercial Distribution
- 00849832013419 ()
- Device Size Text, specify:
- Laboratory instrument/analyser application software IVD