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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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Oximeter - 06938368100022

No Description
General Meditech. Inc.
G1B Plus
Not in Commercial Distribution

  • 06938368100039 ()
  • 06938368100022 ()


  • Pulse oximeter

Oximeter - 06938368100008

No Description
General Meditech. Inc.
G1B
Not in Commercial Distribution

  • 06938368100015 ()
  • 06938368100008 ()


  • Pulse oximeter

Oximeter Plus - 00860298000010

Fingertip Pulse Oximeter
OXIMETER PLUS, INC.
C21
In Commercial Distribution

  • 00860298000010 ()


  • Pulse oximeter

Pylo Health - 00860011521266

LTE connected spot measurement pulse oximeter
Prevounce Health, Inc
OX1-LTE
In Commercial Distribution

  • 00860011521266 ()


  • Pulse oximeter

Algo SaMD - 00860010157008

The all.health Algo SaMD™ Model 1000 oximeter is a pulse oximeter configured to operate in Software as a Medical Device (“SaMD”). The software device is intended to run remotely as an optional cloud service component of a complete all.health ICM™ system, a non-medical-device clinical decision support system. The software device collects input from compatible remote hardware sensor bands or other sensors, then filters, analyzes, and validates the collected data to produce a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygenation (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring. Medical Device Info. • Class II (enforcement discretion) medical device • Regulation: Oximeter, 870.2700 • Rx. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.
All.health, Inc.
Model 1000
In Commercial Distribution

  • 00860010157008 ()
ALGO-m1000-SW (rev 0)

  • Pulse oximeter

Alcedo - 00856471007204

Fingertip Pulse Oximeter
NATURE MAJOR INC
AE174
In Commercial Distribution

  • 10856471007201 ()
  • 00856471007204 ()


  • Pulse oximeter

FDK - 00859020006390

Speaking Blood Oxygen Fingertip Pulse Oximeter
Fudakang Industrial Inc.
FT-E688 Plus
In Commercial Distribution

  • 10859020006397 ()
  • 00859020006390 ()
  • 20859020006394 ()


  • Pulse oximeter

FDK - 00859020006154

Speaking Blood Oxygen Fingertip Pulse Oximeter
Fudakang Industrial Inc.
FT-E688
In Commercial Distribution

  • 10859020006151 ()
  • 00859020006154 ()
  • 20859020006158 ()


  • Pulse oximeter

Sunbeam - 00694501169801

Deluxe Pulse Oximeter
Star Elite Inc
CMS50DA
In Commercial Distribution

  • 00694501169801 ()


  • Pulse oximeter

Beurer - 00853879007119

Bluetooth® Pulse Oximeter for wellnessuse
BEURER NORTH AMERICA, L.P.
PO60 (Art.-No.454.73)
In Commercial Distribution

  • 10853879007116 ()
  • 00853879007119 ()


  • Pulse oximeter
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