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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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FDK - 00859020006154

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

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


  • Pulse oximeter

NuvoMed - 00859811007391

Fingertips Oximeter
NUVOMED, INC.
FPO-6/0739
In Commercial Distribution

  • 00859811007391 ()


  • Pulse oximeter

NuvoMed - 00859811007001

Wireless Finger Oxygen Saturation Monitor
NUVOMED, INC.
NOSM-6/0700
In Commercial Distribution

  • 00859811007001 ()


  • Pulse oximeter

Zewa - 00682891216090

Pulse Ox RX
VERIDIAN HEALTHCARE LLC
21609
In Commercial Distribution

  • 00682891216090 ()


  • Pulse oximeter

Zewa - 00682891216021

Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21602
In Commercial Distribution

  • 00682891216021 ()


  • Pulse oximeter

Zewa - 00682891216014

Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21601
In Commercial Distribution

  • 00682891216014 ()


  • Pulse oximeter

Zewa - 00682891216007

Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21600
In Commercial Distribution

  • 00682891216007 ()


  • 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

Oximeter Plus - 00860298000010

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

  • 00860298000010 ()


  • Pulse oximeter
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