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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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LAPAROSCOPY PACK II
Cardinal Health 200, LLC
SBA23LPHM2
In Commercial Distribution

  • 50195594198587 ()
  • 10195594198589 ()
SBA23LPHM2

  • Decontamination floor mat, single-use
EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments.
MYCARDIUM AI LIMITED
01.01.00(USA)
In Commercial Distribution

  • 05061038730050 ()
EchoConfidence

  • Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-03
In Commercial Distribution

  • 05415067053138 ()
ENSITE-FWV-03

  • Cardiac mapping system application software
Repetitive SpO2 Probe/Masmo/New Lifting Finger Clip/Adult/With Shading/1.1M/108G
Unimed Medical Supplies, Inc.
U403LC-49R
In Commercial Distribution

  • 06936735450039 ()


  • Pulse oximeter probe, reusable
Nexstim NBT White Head Tracker (box of 20) New part list nr NX92463
Nexstim Oyj
NX93874
In Commercial Distribution

  • 06430063200163 ()
NX93874

  • Stereotactic neuronavigation/planning system
Nexstim NBS Orange Head Tracker (box of 20) New part list nr NX103354
Nexstim Oyj
NX92464
In Commercial Distribution

  • 06430063200118 ()
NX103376

  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
Note: KS2-SSSMALLUNSC is new part number for KS2 SSSMALLUNSCE. Product did not change.
King Systems Corporation
KS2-SSSMALLUNSC
Not in Commercial Distribution

  • 00612649176086 ()
  • 00612649205021 ()

  • Small
KS2-SSSMALLUNSC

  • Anaesthesia face mask, single-use
INFANT W/MANOMETER,12" CORRUGATED RESERVOIR,M1& M2 MASK & NEW STYLE O2 RESER
VENTLAB, LLC
VN3106MC-M1-2V
In Commercial Distribution

  • 20889483095994 ()
  • 10889483095997 ()

  • Total Volume: 300 Milliliter


  • Pulmonary resuscitator, manual, single-use
New NK 12 Pin CN to 3 Lead Molded Patient Cable, W/Pinch
Advantage Medical Electronics, LLC
CB-723600/3
In Commercial Distribution

  • 00849593012911 ()


  • Electrical-only medical device connection cable, reusable
Phasitron Kit, IPV HC, Home Care Duo (New name for A50110-HC. Same product.)
PERCUSSIONAIRE CORPORATION
A50110-HC-DUO
Not in Commercial Distribution

  • 00849436000457 ()
A50110-HC-DUO

  • Ventilator breathing circuit, single-use
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