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No Description
BRAEMAR MANUFACTURING, LLC
900-0618-07
In Commercial Distribution
- B146C1MA070 ()
- Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for:
Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-05
In Commercial Distribution
- B146C1MA051010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for:
Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-04
In Commercial Distribution
- B146C1MA041010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for:
Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-03
In Commercial Distribution
- B146C1MA031010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for:
Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-02
In Commercial Distribution
- B146C1MA021010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
The Millennia software system is indicated for:
Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-01
In Commercial Distribution
- B146C1MA011010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmia.
To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-00
In Commercial Distribution
- B146C1MA001010 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0621-08
In Commercial Distribution
- B146C4MA080 ()
- Electrocardiographic long-term ambulatory recording analyser application software
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.2
In Commercial Distribution
- B180BSB01120 ()
BSB01
- Blood bank information system application software
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.1
In Commercial Distribution
- B180BSB01110 ()
BSB01
- Blood bank information system application software
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.0
In Commercial Distribution
- B180BSB01100 ()
BSB01
- Blood bank information system application software
No Description
ECENTIAL ROBOTICS
L00016
In Commercial Distribution
- 03701311500445 ()
- Robotic surgical navigation system application software
The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution
- 08719481550332 ()
- Biofeedback system application software
Raypilot Software, including user friendly functions, is installed on a dedicated computer and visualized on a display in the control as well as treatment room.
Micropos Medical AB (Publ)
1
In Commercial Distribution
- 07350007953049 ()
3004
- Radiation therapy invasive marker lesion localization system
moorVMS-PC Software V4.0 is a Windows based software package designed to work with the moorVMS setup and is fully compatible with all of the existing modules.
MOOR INSTRUMENTS LIMITED
4
In Commercial Distribution
- 15060484490096 ()
- Tissue saturation oximeter
- Laser Doppler blood flowmeter
No Description
PATHKEEPER SURGICAL LTD
PSW0001-01
In Commercial Distribution
- 07290019120148 ()
- Optical surgical navigation device tracking system
iCodeConnect Software
BMC Medical Co., Ltd.
420002
In Commercial Distribution
- 06948538362075 ()
- Ventilator application software
tetraONE
Beckman Coulter, Inc.
6915050
In Commercial Distribution
- 15099590572679 ()
6915050
- Laboratory instrument/analyser application software IVD
stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution
- 15099590559519 ()
6915452
- Laboratory instrument/analyser application software IVD
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution
- 07290114064545 ()
407-000024-00
- Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution
- 07290114064071 ()
407-000024-00
- Brain-responsive electrical stimulation system
Philips Holter Software w/ Zymed Alg
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution
- 00884838094895 ()
860292
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution
- 00884838000469 ()
860292
- Electrocardiographic ambulatory recorder
TAPES primary packaging (x1)
Endo Tools Therapeutics
TAPES
In Commercial Distribution
- 05425029282698 ()
- 05425029282094 ()
- 05425029282391 ()
- 05425029282995 ()
- 05425029282919 ()
- 05425029282988 ()
- 05425029282933 ()
- 05425029282964 ()
- Suturing unit, single-use
endomina system is composed of 1 endomina platform and 6 TAPES
Endo Tools Therapeutics
endomina system
In Commercial Distribution
- 05425029282070 ()
- 05425029282971 ()
- Endoscopic overtube, single-use
- Suturing unit, single-use
endomina platform primary packaging (x1)
Endo Tools Therapeutics
endomina platform
In Commercial Distribution
- 05425029282117 ()
- 05425029282018 ()
- 05425029282339 ()
- 05425029282940 ()
- 05425029282957 ()
- 05425029282926 ()
- Endoscopic overtube, single-use
Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
O.B - TOOLS LTD
FG0003(X)
Not in Commercial Distribution
- 07290016406030 ()
- 17290016406037 ()
- 27290016406034 ()
- Width: 280 Millimeter
- Length: 320 Millimeter
FG0003(X)
- Cardiotocography telemetric monitoring system
The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring system. The corresponding Maternal Unit transmits the uterine activity/fetal heart rate information via Bluetooth to the MONITOR ADAPTER which transfers it to the hospital monitor or directly to the hospital IT system.
O.B - TOOLS LTD
FG0002(X)
In Commercial Distribution
- 07290016406023 ()
- Depth: 30 Millimeter
- Width: 200 Millimeter
- Height: 120 Millimeter
- Weight: 400 Gram
FG0002(X)
- Cardiotocography telemetric monitoring system
TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrace electrode array. The MU acquires EMG signals and provides Fetal Heart Rate and Uterine Activity are transmitted via Bluetooth. The unit contains a Li-Ion rechargeable battery.
O.B - TOOLS LTD
FG0001(X)
In Commercial Distribution
- 07290016406016 ()
- Width: 90 Millimeter
- Height: 125 Millimeter
- Depth: 29 Millimeter
- Weight: 240 Gram
FG0001(X)
- Cardiotocography telemetric monitoring system
ZephyrLIFE Hospital Application Software Application?
ZEPHYR TECHNOLOGY LLC
Software Hospital
Not in Commercial Distribution
- 10884521712904 ()
Software Hospital
- Electrosurgical return electrode, single-use
ZephyrLIFE Home HealthHub Patient Software Application?
ZEPHYR TECHNOLOGY LLC
Software Home
Not in Commercial Distribution
- 10884521712898 ()
Software Home
- Electrosurgical return electrode, single-use
hi-PS (Programming Software) Fitting Software, Solo
INTRICON CORPORATION
hi-PS Solo
In Commercial Distribution
- 00858177007151 ()
23126
- Hearing aid wireless-fitting computer-aided set
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-04-00-000
In Commercial Distribution
- 00817100020438 ()
- Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-03-04-000
In Commercial Distribution
- 00817100020421 ()
- Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution
- 00817100020414 ()
- Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ 04-02-01-000
In Commercial Distribution
- 00817100020186 ()
- Diagnostic x-ray digital imaging system workstation application software
SOFTWARE GE CLIENT SOFTWARE V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution
- 00840682123532 ()
- Cardiac catheterization monitoring system
- Cardiac electrophysiology analysis system
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2039
Not in Commercial Distribution
- 04953170360824 ()
N5368940
- Video capsule endoscopy system application software
Flexible Reamer 6.0, 160mm Cannulated
Trimed, INC.
RMRFLX-6.0/160C
In Commercial Distribution
- 00842188119477 ()
RMRFLX-6.0/160C
- Bone-resection orthopaedic reamer, single-use
Interlocking Guide, Drill Sleeve 2.3
Trimed, INC.
SLVGDI-2.3
In Commercial Distribution
- 00842188119446 ()
SLVGDI-2.3
- Surgical drill guide, reusable
Hex Driver 3.5, 130mm Cannulated TriLobe
Trimed, INC.
DVHX-3.5/130C TL
In Commercial Distribution
- 00842188119422 ()
DVHX-3.5/130C TL
- Surgical screwdriver, reusable
Hex Driver 2.5, 110mm AO Nipple Tip
Trimed, INC.
DVHX-2.5/110N AO
In Commercial Distribution
- 00842188119385 ()
DVHX-2.5/110N AO
- Surgical screwdriver, reusable
Radial Shortening Osteotomy Tray
Trimed, INC.
RSO-TRAY
Not in Commercial Distribution
- 00842188115462 ()
RSO-TRAY
- Instrument tray, reusable
Radial Osteotomy Saw Guide, 3mm
Trimed, INC.
GSRSO-3
In Commercial Distribution
- 00842188115455 ()
GSRSO-3
- Osteotomy guide, reusable
Radial Osteotomy Saw Guide, 2mm
Trimed, INC.
GSRSO-2
In Commercial Distribution
- 00842188115448 ()
GSRSO-2
- Osteotomy guide, reusable
Crosslock Guide 2.3
Trimed, INC.
GDXDH-2.3
In Commercial Distribution
- 00842188115417 ()
GDXDH-2.3
- Surgical drill guide, reusable
Interlocking Guide, Wire Gauge
Trimed, INC.
SLVWIRE-2.0/125
In Commercial Distribution
- 00842188115400 ()
SLVWIRE-2.0/125
- Surgical depth gauge, reusable
Interlocking Guide, Drill Sleeve 2.3, 60mm
Trimed, INC.
SLVGDI-2.3/060
Not in Commercial Distribution
- 00842188115394 ()
SLVGDI-2.3/060
- Surgical drill guide, reusable
Impactor, Medial Nail
Trimed, INC.
IMPCT-DHMN
In Commercial Distribution
- 00842188115387 ()
IMPCT-DHMN
- Orthopaedic implant impactor, reusable
Interlocking Guide, Medial Nail, Right
Trimed, INC.
GDI-DHMNR
In Commercial Distribution
- 00842188115370 ()
GDI-DHMNR
- Surgical drill guide, reusable