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The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.
Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
Tem Innovations GmbH
sigma ROTROL N
In Commercial Distribution
- 04260160470617 ()
- 04260160470341 ()
555201
- Multiple coagulation factor IVD, control
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.
Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
Tem Innovations GmbH
sigma complete + hep
In Commercial Distribution
- 04260160470600 ()
- 04260160470327 ()
555502
- Multiple coagulation factor IVD, kit, clotting
The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive device for screening the hearing of infants between the ages of 34 weeks corrected gestational age and six months. The screener uses Natus’ AABR® technology. Babies should be well enough for hospital discharge, and should be asleep or in a quiet state at the time of screening. The ALGO 3i screener is simple to operate and does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants correctly. A typical screening can be completed in 15 minutes or less in any clinical environment (i.e. well-baby nursery, NICU, mother’s bedside, audiology suite, outpatient clinic, or doctor’s office).
NATUS MEDICAL INCORPORATED
Algo 3i
In Commercial Distribution
- 00382830053297 ()
040695, 040969
- Evoked-potential audiometer
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution
- 04987669100530 ()
- Optical pachymeter
- Direct ophthalmoscope, line-powered
The Nova HD Pulsed Electronic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, The Aura is easy to operate and incorporates many features to promote human health and well-being.
The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body.
The Nova HD is intended to be operated and used by the same person.
The Nova HD produces non ionizing pulsed electromagnetic field at the applicator.
Aura Wellness, LLC
Nova HD Starter Kit
In Commercial Distribution
- 00850026680065 ()
APN-00026
- Deep-tissue electromagnetic stimulation system, home-use
The Nova HD Pulsed Electronic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, The Aura is easy to operate and incorporates many features to promote human health and well-being.
The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body.
The Nova HD is intended to be operated and used by the same person.
The Nova HD produces non ionizing pulsed electromagnetic field at the applicator.
Aura Wellness, LLC
Nova HD
In Commercial Distribution
- 00850026680003 ()
NOVA HD
- Deep-tissue electromagnetic stimulation system, home-use
Kit Includes:
(T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider
(R138) Montana Jack™
(R223) 23 Explorer-12 Probe
(R245) Cone Socket Mirror Handle
(R269) 3-6 Discoid-Cleoid Carver
(R284) Hollenback 1/2-3 Carver
(R286) G2 Thin Composite
(R287) G3 Thin Composite
(R333) 27-29 Burnisher
(R336) Calcium Hydroxide Placer
(R347) 0-1 Blacks Plugger
(R362) 113 Off Angle Cord Packer
(R375) Mixing Spatula-Applicator
(R386) 38-39 Excavator
(R534) IPC-T Gold Line™ (Composite Sculpting System)
(T042) Meriam Tweezers
(T046) Miller Articulating Paper Forceps
(T050) #5 Mirror (15/16")
(T235) Aspirating Anesthetic Syringe Medium
(T356) Amalgam Well
(T800) Iris Curved Scissors (11.5cm)
PDT, INC.
R937 PDT Total Restorative Kit
In Commercial Distribution
- 00813677024978 ()
R937
- Instrument tray, reusable
- Dental mirror, reusable
- Dental irrigation/aspiration syringe
- Manual dental scaler, reusable
- Dental surgical probe, reusable
- Manual non-rotary dental instrument handle
- Dental restoration carver, resin
- Surgical soft-tissue manipulation forceps, tweezers-like, reusable
- Dental restoration carver, amalgam, reusable
- Manual dental burnisher, reusable
- Dental amalgam condenser, reusable
- Dental amalgam well
- Gingival retraction cord packing tool
- Dental spatula, reusable
- Dental excavator, reusable
- Suture scissors
The Televisit software is intended for the purposes of collecting physiological data such as: Non-Invasive Blood Pressure; Pulse Oximetry, Temperature and Breath Sounds (Auscultation), Spirometer, Glucometer and E.C.G.
The intended use of the Televisit software is in hospital/clinical environments with established specialized care providing access to each patient in their home and/or local community health center. Televisit software is a non-invasive medical device, which does not flag any abnormal results from the medical device inputs. The Televisit software does not monitor, assess or diagnose a disease, a disorder, or an abnormal physical state. The intended use for the software is data acquisition and collection only, with no treatment function or danger to the end user. The data obtained from Televisit software can be used only as an aid in the diagnosis and treatment of the patient.
Primonics (2006) Inc
TVS
In Commercial Distribution
- 00628250477016 ()
- Pulse oximeter, line-powered
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
The star-tem® reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM® delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem® reagent (REF 503-02-US), resp.
Tem Innovations GmbH
star-tem® 20
In Commercial Distribution
- 04260160470099 ()
- 04260160470518 ()
503-10-US
- Multiple coagulation factor IVD, reagent
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