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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5026
In Commercial Distribution

  • 08806387850267 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5025
In Commercial Distribution

  • 08806387850250 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5000
In Commercial Distribution

  • 08806387850007 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0006415
In Commercial Distribution

  • 10888234002017 ()
0006415

  • Anti-Rh(D) red blood cell grouping IVD, antibody
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
Micro-Albumin is a competitive ELISA test system for the quantitative measurement of human albumin in urine. This product is intended for professional in vitro diagnostic use only. The rate of albumin excertion in urine is an important control and prevention parameter for the evaluation of kidney function. If the glomerular filtration process is highly active, albumin excretion may be elevated without any kidney damage. Physical stress may also cause microalbuminuria.
ORGENTEC Diagnostika GmbH
ORG 5MA
Not in Commercial Distribution

  • 00198168683255 ()
ORG 5MA

  • Albumin IVD, kit, enzyme immunoassay (EIA)
Stat Profile pHOx Ultra/CCX Sensor Multi blank
NOVA BIOMEDICAL CORPORATION
pHOx Ultra/CCX
In Commercial Distribution

  • 00385480492058 ()
49205

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile pHox Ultra/CCX Blank Sensor Gas
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480492041 ()
49204

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
TUBING ASSEMBLIES L4,L5,L6 STP PHOX ULTRA/CCX
NOVA BIOMEDICAL CORPORATION
pHOx Ultra/CCX
In Commercial Distribution

  • 00385480489553 ()
48955

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
TUBING ASSEMBLIES L1,L2,L3 STP PHOX ULTRA/CCX
NOVA BIOMEDICAL CORPORATION
pHOx Ultra/CCX
In Commercial Distribution

  • 00385480489546 ()
48954

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
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