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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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3M™ Littmann® Electronic Stethoscope, Black, 27", USA / Japan Only 3100BK
3M COMPANY
3100BK27
In Commercial Distribution

  • 50707387765458 ()
  • 00707387765453 ()
3100BK27

  • Electronic acoustic stethoscope
3M™ Littmann® Electronic Stethoscope, Burgundy, 27", USA / Japan Only 3200BU
3M COMPANY
3200BU
In Commercial Distribution

  • 50707387765441 ()
  • 00707387765446 ()
3200BU

  • Electronic acoustic stethoscope
3M™ Littmann® Electronic Stethoscope, Navy Blue, 27", USA / Japan Only 3200NB
3M COMPANY
3200NB
In Commercial Distribution

  • 50707387765434 ()
  • 00707387765439 ()
3200NB

  • Electronic acoustic stethoscope
3M™ Littmann® Electronic Stethoscope, Black, 27", USA / Japan Only 3200BK
3M COMPANY
3200BK27
In Commercial Distribution

  • 50707387765427 ()
  • 00707387765422 ()
3200BK27

  • Electronic acoustic stethoscope
Well at Walgreens Dual Frequency Stethoscope
WALGREEN CO.
786610
In Commercial Distribution

  • 10311917206179 ()
  • 00311917206172 ()


  • Electronic acoustic stethoscope
No Description
ECHONOUS, INC.
R006115
In Commercial Distribution

  • 09353278000489 ()


  • Electronic acoustic stethoscope
Electronic stethoscope
ECHONOUS, INC.
P006115
In Commercial Distribution

  • 09353278000212 ()


  • Electronic acoustic stethoscope
The M3DICINE Stethee™ Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment. Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable sample recording, playback, visualization, analysis, reporting and sharing with other authorized users.
M3DICINE PTY LTD
1
In Commercial Distribution

  • 09351356000017 ()


  • Electronic acoustic stethoscope
The Thinklabs One Digital Stethoscope is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any use except as indicated. The Thinklabs One is designed to be used by medical and allied professionals and trainees enrolled in professional training programs. Operation of the device requires no special training beyond the user following the instructions for use on Thinklabs website. Accurate patient diagnosis with a stethoscope requires the operator to have auscultation skills.
THINKLABS MEDICAL, LLC
One
In Commercial Distribution

  • 00899529001106 ()

  • Weight: 0.075 Pound
  • Height: 1.2 Inch
  • Outer Diameter: 1.75 Inch


  • Electronic acoustic stethoscope
RAS-45 Inf/Neo RRa Infant/Neonatal Acoustic Respiration Sensor
MASIMO CORPORATION
4425
In Commercial Distribution

  • 00843997013116 ()
  • 10843997013113 ()


  • Electronic acoustic stethoscope
RAS Rra Training Kit application training packet
MASIMO CORPORATION
4287
In Commercial Distribution

  • 10843997012550 ()


  • Electronic acoustic stethoscope
No Description
MASIMO CORPORATION
4171
In Commercial Distribution

  • 10843997009635 ()
  • 00843997009638 ()


  • Electronic acoustic stethoscope
RAS-125c, Adult/Ped Short Term Monitoring, Acoustic Respiration Cloth Sensor
MASIMO CORPORATION
3483
In Commercial Distribution

  • 10843997007440 ()
  • 00843997007443 ()
3483

  • Electronic acoustic stethoscope
RAS-125c short term monitoring acoustic respiration cloth sensor
MASIMO CORPORATION
3401
In Commercial Distribution

  • 10843997007426 ()
  • 00843997007429 ()
3401

  • Electronic acoustic stethoscope
No Description
MASIMO CORPORATION
3456
In Commercial Distribution

  • 10843997007358 ()


  • Electronic acoustic stethoscope
MasimoSET® rainbow RAS-125c adult/pediatric acoustic respiration cloth sensor
MASIMO CORPORATION
3475
In Commercial Distribution

  • 10843997007068 ()
  • 00843997007061 ()
3475

  • Electronic acoustic stethoscope
Radius VSM RAS-45 Acoustic Respiration Sensor, Adult, 10/Box
MASIMO CORPORATION
4828
In Commercial Distribution

  • 00843997006187 ()
  • 10843997006184 ()


  • Electronic acoustic stethoscope
E-Scope Hearing Impaired
CARDIONICS INC
7187710
In Commercial Distribution

  • B37871877100 ()
718-7710

  • Electronic acoustic stethoscope
Clinical E-Scope
CARDIONICS INC
7187700
In Commercial Distribution

  • B37571877000 ()
718-7700

  • Electronic acoustic stethoscope
The Tyto Insights for Crackles Detection is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Crackle” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Crackles Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.
TYTO CARE LTD
Tyto Insights for Crackles Detection
In Commercial Distribution

  • 07290020123008 ()


  • Electronic acoustic stethoscope
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