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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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AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water for wound flush are intended to be used in clinical care and should only be used by clinicians familiar with the treatment of possible complications.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 00704411007459 ()
  • 40704411007457 ()
AS399

  • Wound irrigation sterile saline
The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma glucose concentration which can be a sign of diabetes or other medical problems. The Chemcard™ Glucose Test provides a preliminary, semi-quantitative result using fingerstick blood as the test specimen. 510K Cleared - CliaWaived
CHEMATICS, INC.
47000
In Commercial Distribution

  • 00737051736922 ()
  • 00737051736915 ()
  • 00737051736908 ()


  • Glucose IVD, kit, colorimetric dipstick, rapid
The SURGmatic S15 L Pro handpiece is intended for: • Oral, jaw and facial surgery • Tooth extraction procedures • Root resection • Osteotomy • Removal of carious material • Tooth, cavity and crown preparations • Processing of fillings The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and / or oral surgery.
KaVo Dental GmbH
1.014.4000
In Commercial Distribution

  • EKAV101440000 ()
S15 L Pro

  • Dental power tool system handpiece, line-powered
The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario USB-C meter is connected to a SMD connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C blood glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. Dario USB-C Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
LABSTYLE INNOVATION LTD
1193-05
In Commercial Distribution

  • 00850065006505 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
  • Glucose monitoring system IVD, home-use
The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. Dario LC Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
LABSTYLE INNOVATION LTD
1183-05
In Commercial Distribution

  • 00850065006451 ()


  • Glucose monitoring system IVD, home-use
  • Glucose IVD, kit, enzyme spectrophotometry, rapid
The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. This re-usable device is intend to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting. The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful. The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach).
INTELESENS LIMITED
PN1111
In Commercial Distribution

  • 05060484630020 ()
  • 15060484630027 ()


  • Electrocardiography telemetric monitoring system
SS Utility Table with 4 Drawers and 3-Sided Guardrail. 2 locking caster on front to secure unit in place. Shelf and top are constructed of 16 gauge stainless steel. Square legs offer more welding surface and more material for added strength and longevity. These tables are manufactured to our OR specifications and do not have any open cavities to collect unwanted substances. Drawers mounted on ball bearing glides. Full extension drawers make the whole drawer easy to access. Stainless steel rod handle. Non-marking neoprene 3" casters come standard to make it easy to maneuver and protect the floors in your facility. All edges are glove friendly. No open cavities to collect unwanted substances. Ships fully assembled. .
MID CENTRAL MEDICAL CORP.
MCM523
In Commercial Distribution

  • 10810030861925 ()

  • Width: 16 Inch
  • Length: 20 Inch
  • Height: 34 Inch
MCM523

  • Operating table accessory trolley
SS Utility Table with 3 Drawers and 3-Sided Guardrail. 2 locking caster on front to secure unit in place. Shelf and top are constructed of 16 gauge stainless steel. Square legs offer more welding surface and more material for added strength and longevity. These tables are manufactured to our OR specifications and do not have any open cavities to collect unwanted substances. Drawers mounted on ball bearing glides. Full extension drawers make the whole drawer easy to access. Stainless steel rod handle. Non-marking neoprene 3" casters come standard to make it easy to maneuver and protect the floors in your facility. All edges are glove friendly. No open cavities to collect unwanted substances. Ships fully assembled. .
MID CENTRAL MEDICAL CORP.
MCM522
In Commercial Distribution

  • 10810030861918 ()

  • Width: 16 Inch
  • Length: 20 Inch
  • Height: 34 Inch
MCM522

  • Operating table accessory trolley
SS Utility Table with 2 Drawers and 3-Sided Guardrail. 2 locking caster on front to secure unit in place. Shelf and top are constructed of 16 gauge stainless steel. Square legs offer more welding surface and more material for added strength and longevity. These tables are manufactured to our OR specifications and do not have any open cavities to collect unwanted substances. Drawers mounted on ball bearing glides. Full extension drawers make the whole drawer easy to access. Stainless steel rod handle. Non-marking neoprene 3" casters come standard to make it easy to maneuver and protect the floors in your facility. All edges are glove friendly. No open cavities to collect unwanted substances. Ships fully assembled. .
MID CENTRAL MEDICAL CORP.
MCM521
In Commercial Distribution

  • 10810030861901 ()

  • Width: 16 Inch
  • Length: 20 Inch
  • Height: 34 Inch
MCM521

  • Operating table accessory trolley
Utility Table with 3-sided guardrail and 1 lower drawer. 2 locking caster on front to secure unit in place. Shelf and top are constructed of 16 gauge stainless steel. Square legs offer more welding surface and more material for added strength and longevity. These tables are manufactured to our OR specifications and do not have any open cavities to collect unwanted substances. Drawers mounted on ball bearing glides. Full extension drawers make the whole drawer easy to access. Stainless steel rod handle. Non-marking neoprene 3" casters come standard to make it easy to maneuver and protect the floors in your facility. All edges are glove friendly. No open cavities to collect unwanted substances. Ships fully assembled. .
MID CENTRAL MEDICAL CORP.
MCM520
In Commercial Distribution

  • 10810030861895 ()

  • Width: 16 Inch
  • Length: 20 Inch
  • Height: 34 Inch
MCM520

  • Operating table accessory trolley
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