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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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Xianhe Desktop TDP Infrared Therapy Lamp - B465CQ180

The CQ-18 / D-05 TDP therapy lamp head contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating element begins to emit FIR (far infrared) waves along with the ionized minerals which easily penetrates deep into the body to be absorbed. The CQ-36 lamp is a desk lamp with the control panel built into the base. The articulating arm allows you to easily position the emission head at different heights, while tilt and swivel head allows for multiple angles of treatment.
A & A MEDICAL SUPPLIES INC.
CQ-18
In Commercial Distribution

  • B465CQ180 ()

  • Adjustable Min/Max Height: 33.5"/62" above floor
  • Width: 24 Inch
  • Weight: 25 Pound
D-05

  • Musculoskeletal infrared phototherapy unit, non-wearable

Reliefband® Premier Plus - 00661168000181

Reliefband® Premier Plus is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic band with a control panel on top and two electrical contacts underneath. The two contacts must be placed firmly against the underside of your wrist at the P6 location. Reliefband Premier Plus is your everyday wearable, providing an advanced nausea relief solution, unparalleled convenience, and efficiency with a digital display, clock, and Smart Skin-Sensing technology to preserve battery life. A fully charged battery will last for approximately 18 -25 hours of continuous use at the mid-power level or below.
RELIEFBAND TECHNOLOGIES LLC
RBPLUS
In Commercial Distribution

  • 10661168000188 ()
  • 00661168000181 ()
  • 20661168000185 ()


  • Anti-nausea transcutaneous electrical nerve stimulation wristband

CPRmeter - 07045432055290

The CPRmeter™ CPR feedback device is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim. The feedback is provided in accordance with the 2010 versions of the guidelines for resuscitation published by the International Liaison Committee on Resuscitation (ILCOR), American Heart Association (AHA), and European Resuscitation Council (ERC) (hereinafter referred to as “CPR Guidelines”). The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. The CPRmeter device provides feedback on CPR via a display panel to improve responders’ compliance with CPR Guidelines.
Laerdal Medical AS
801
Not in Commercial Distribution

  • 07045432055290 ()
801-00149

  • Cardiopulmonary resuscitation feedback device, electronic

Radiography 7000 M - 00884838115521

Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small)
Philips Medical Systems DMC GmbH
712010
In Commercial Distribution

  • 00884838115521 ()


  • Mobile basic diagnostic x-ray system, digital

Precision CRF - 00884838110588

The Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes • Footrest • Hand Grips Radiation Protection Accessories • Flexible Radiation Protection Apron • Front Radiation Protection Apron Additional Accessories (Optional) • Monitor Trolley • Monitor Ceiling Suspension • Parking Frame for Accessories • Shoulder Support • Side bar • Compression Belt • Adjustable Lateral Cassette Holder • Leg Supports • Infusion Bottle Holder • Arm Support for Catheterization • Ankle Clamps • Overhead Hand Grip • Adult Headrest • Mattress • Rotatable Stool for Footrest • Pediatric Micturition Set • Stretch Grip for Wall Stand • Bar Code Scanner • Patient Support • Stitching Ruler Accessories for the SkyPlate Detector (Optional) • Mobile Detector Holder • Detector Holder Patient Bed • Portable Panel Protector • Detector Handle • WPD Bags • Grids for SkyPlate Detector large
Philips Medical Systems DMC GmbH
706400
In Commercial Distribution

  • 00884838110588 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

ProxiDiagnost N90 - 00884838103221

The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes • Footrest • Hand Grips Radiation Protection Accessories • Flexible Radiation Protection Apron • Front Radiation Protection Apron Additional Accessories (Optional) • Monitor Trolley • Monitor Ceiling Suspension • Parking Frame for Accessories • Shoulder Support • Side bar • Compression Belt • Adjustable Lateral Cassette Holder • Leg Supports • Infusion Bottle Holder • Arm Support for Catheterization • Ankle Clamps • Overhead Hand Grip • Adult Headrest • Mattress • Rotatable Stool for Footrest • Pediatric Micturition Set • Stretch Grip for Wall Stand • Bar Code Scanner • Patient Support • Stitching Ruler Accessories for the SkyPlate Detector (Optional) • Mobile Detector Holder • Detector Holder Patient Bed • Portable Panel Protector • Detector Handle • WPD Bags • Grids for SkyPlate Detector large
Philips Medical Systems DMC GmbH
706110
In Commercial Distribution

  • 00884838103221 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

Piccolo Kidney Check - EABA40000331

The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0033
In Commercial Distribution

  • EABA40000331 ()
  • EABA40000330 ()
400-0033

  • Urea IVD, reagent
  • Creatinine IVD, reagent

MOCACuff - 00850842006063

MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s wrist. All values can be read out in one LD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3~7.7 inch. The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Further, HL168KF feature a built-in Bluetooth Data Transmission function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.
MOCACARE CORP.
White (HL168KF)
In Commercial Distribution

  • 00850842006063 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

IOPS™ Software Application - 00843152104000

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution

  • 00843152104000 ()
SW-1

  • Electromagnetic surgical navigation device tracking system

IOPS Mobile Cart - 00843152100002

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
MC-1
In Commercial Distribution

  • 00843152100002 ()
MC-1

  • Electromagnetic surgical navigation device tracking system
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