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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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Polysmith Sleep System - 00841983103131

Polysomnography Sleep System Version 9
NIHON KOHDEN AMERICA, INC.
A/ONEBED-SCORE-9X
In Commercial Distribution

  • 00841983103131 ()
A/ONEBED-SCORE-9X

  • Sleep disorder interpretive software

NA - 00841983104114

DOWN POLE CLAMP FOR AE-918 EEG MODULE
NIHON KOHDEN AMERICA, INC.
A/0059-01
In Commercial Distribution

  • 00841983104114 ()
A/0059-01

  • Instrument trolley

NA - 00841983104107

DAU BOTTOM PLATE MOUNT FOR AE-918 EEG POD
NIHON KOHDEN AMERICA, INC.
A/0055-62
In Commercial Distribution

  • 00841983104107 ()
A/0055-62

  • Instrument trolley

Polysmith Sleep System - 00841983104008

Polysomnography Sleep System Version 11
NIHON KOHDEN AMERICA, INC.
A/ONEBED-SCORE-11X
In Commercial Distribution

  • 00841983104008 ()
A/ONEBED-SCORE-11X

  • Sleep disorder interpretive software

NA - 00841983103902

POUCH, NIBP, ZM-540PA
NIHON KOHDEN AMERICA, INC.
A/NTX2-POUCH
In Commercial Distribution

  • 00841983103902 ()
A/NTX2-POUCH

  • Electrocardiography telemetric monitoring system transmitter

Bausch + Lomb - 00757770529285

LARYNGECTOMY TUBE NYLON SIZE-8
Bausch & Lomb Incorporated
N8182 A
In Commercial Distribution

  • 00757770529285 ()
N8182 A

  • Laryngectomy tube, non-sterile

Coala Heart Monitor US Rx - 07350002700105

The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.
Coala-Life AB
201
In Commercial Distribution

  • 27350002700123 ()
  • 07350002700105 ()
  • 17350002700119 ()
N/A

  • Phonocardiograph
  • Electrocardiograph, home-use

extriCARE - 00879766005464

2400 Pump set with a canister in a box
OAKWELL DISTRIBUTION, INC.
EC2400-E
In Commercial Distribution

  • 10879766005461 ()
  • 00879766005464 ()


  • Multi-purpose low-vacuum suction system

INTRAflex LUX2 2325 LN - EKAV053562100

This is a medical device.This is a medical device.
KaVo Dental GmbH
0.535.6210
In Commercial Distribution

  • EKAV053562100 ()
2325 LN

  • Dental power tool system handpiece, pneumatic

INTRAflex LUX2 2307 LN - EKAV053561900

This is a medical device.This is a medical device.
KaVo Dental GmbH
0.535.6190
In Commercial Distribution

  • EKAV053561900 ()
2307 LN

  • Dental power tool system handpiece, pneumatic
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