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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 NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
NEOCOIL, LLC
10
In Commercial Distribution

  • 00856181003107 ()


  • MRI system coil, radio-frequency
Picis Weight Based Dose Converter: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007085 ()


  • Patient health record information system application software
Picis Perioperative and Critical Care: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007078 ()


  • Patient health record information system application software
The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 2 gallon four pack sharps disposal ship back system (Includes four 2 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
10
In Commercial Distribution

  • 10853022008076 ()
  • 00853022008062 ()

  • Total Volume: 2.0 Gallon
40042

  • Sharps container
ProOcular Daily Disposable Contact Lens Power -10
CARLSBAD TECHNOLOGY INC.
-10
Not in Commercial Distribution

  • 40816816880655 ()
  • 30816816880658 ()
  • 10816816880654 ()
  • 00816816880657 ()


  • Soft corrective contact lens, daily-disposable
Sample collection kit
Biodesix, Inc.
10
In Commercial Distribution

  • G292510 ()
51

  • Blood collection set, invasive
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
An electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.
Garaventa (Canada) Ltd.
10
In Commercial Distribution

  • B24010 ()


  • Stairlift, chair
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