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VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate specific antigen (PSA) in human serum, using an enzyme immunoassay (EIA) method.
BIOMERIEUX SA
TPSA
Not in Commercial Distribution
- 03573026156985 ()
30428-01
- Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution
- 00817491023612 ()
FG-5502-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution
- 00817491023537 ()
FG-5502-02-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution
- 00817491022387 ()
FG-5502-01-300
- Implantable glucose monitoring system
XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment.
Xvivo Perfusion AB
19023
Not in Commercial Distribution
- 07350069520500 ()
19023
- Lung donor-organ preservation/evaluation system lung-interface set
The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock. During a rescue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC). The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.)
It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load.
The i-PAD NFI200 is capable of saving data and transmitting them to an external device.
Indications for Use
The i-PAD NFI200 is used to treat a person suffering from sudden cardiac arrest
(SCA) and who exhibits symptoms of
· No movement and no response when shaken
· No normal breathing
Contraindication for Use
The device must not be used on a person who:
* Is moving or is responsive when shaken
* Is breathing normally
Target Patients
* Adults
* Children over 55 lbs or 8 years old
* The device is not to be used on children below 8 years old or under 55 lbs
Intended User
The device is intended for use by persons:
* who have been specifically trained in its operation
* who have training in cardiopulmonary resuscitation (CPR) or other physician-authorized emergency medical response program in accordance with local and state requirements
CU Medical Systems, Inc.
NF1200
In Commercial Distribution
- 08809435480003 ()
- Non-rechargeable public semi-automated external defibrillator
SYNVISC ONE (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. SYNVISC ONE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
58468-0090-3
In Commercial Distribution
- 08437027710049 ()
- Synovial fluid supplementation medium
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from
the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive,
and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS465
Not in Commercial Distribution
- 08595231700062 ()
- 08595231704657 ()
- 08595231700055 ()
- Length: 65 Millimeter
- Outer Diameter: 4 Millimeter
- Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from
the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive,
and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS455
Not in Commercial Distribution
- 08595231700048 ()
- 08595231704558 ()
- 08595231700031 ()
- Length: 55 Millimeter
- Outer Diameter: 4 Millimeter
- Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string.
Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS355
Not in Commercial Distribution
- 08595231703551 ()
- 08595231700024 ()
- 08595231700017 ()
- Outer Diameter: 3 Millimeter
- Length: 55 Millimeter
- Hygroscopic cervical dilator