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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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Therm-X Pro
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Pro
In Commercial Distribution

  • 00850001096003 ()
TX0001

  • Inflatable hot/cold therapy pack/electric pump
Tablo Console
Outset Medical, Inc.
PN-0006000
In Commercial Distribution

  • 00850001011204 ()


  • Haemodialysis system, institutional/home-use
The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
Vitrolife A/S
ESD20000
In Commercial Distribution

  • 05712714603013 ()
ESD20000

  • Assisted reproduction incubator/microscope camera system
No Description
WAL-MART STORES, INC.
HTD8813C
In Commercial Distribution

  • 10681131405895 ()
  • 00681131405898 ()
  • 20681131405892 ()
HTD8815US

  • Infrared patient thermometer, skin
DCS 010 Drainage Collection System
Irras USA, Inc.
DCS 010
In Commercial Distribution

  • 10868643000477 ()
  • 00868643000470 ()
DCS 010

  • Intracerebral sensor catheter, short-term
  • Intracranial pressure monitor
The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV
Phillips-Medisize A/S
VYAFUSER PUMP KIT US/PR A
In Commercial Distribution

  • 05713495001043 ()
  • 05713495000152 ()
  • 05713495000169 ()

  • Length: 6.7 Inch
  • Width: 3 Inch
  • Depth: 1.3 Inch
  • Weight: 285 Gram
2089870410

  • Ambulatory syringe pump
Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
NERBIO PRIVATE LIMITED
ITOFDEV01
In Commercial Distribution

  • 00860012119660 ()
  • 00860012119677 ()


  • Block-monitoring peripheral nerve electrical stimulation system
DispenSecur is a device intended for medical purposes to provide alerts and controlled patient access to medication based on dosing schedules predetermined by a healthcare provider. The device may be used with either liquid or solid dosage forms of one medication type. The device is not intended to manage multiple medications.
Verinetics Inc
1
In Commercial Distribution

  • 00860011977513 ()


  • Personal pill dose dispenser, electric
The CarePath system facilitates evaluations measuring urine output. It consists of the CarePath device, accompanying documents, and training. The system: • Measures and calculates flow rate and volume from urination data • Automatically transmits urination data to a secure location • Creates and provides uroflow reports to healthcare providers The intended operator of the CarePath device is the patient. The CarePath system has no user-serviceable components. This system is not to be serviced or maintained by the user. The intended environments are hospitals, clinics, doctor’s offices and the patient’s home.
I/O Urology Corp.
DCDUFD-001M
In Commercial Distribution

  • 00860010862209 ()


  • Urine flowmeter, reusable
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV350
In Commercial Distribution

  • 00860008259233 ()


  • Electrocardiography telemetric monitoring system
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