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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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OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution

  • 14953170373760 ()
  • 04953170373763 ()
N5400340

  • Video capsule endoscopy system application software
No Description
Icad, Inc.
V10
In Commercial Distribution

  • 00850008977046 ()


  • Radiology DICOM image processing application software
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Marijuana (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazpines (BZO), Ecstasy (MDMA).
GERMAINE LABORATORIES, INC
40125
In Commercial Distribution

  • 00695684401252 ()
  • 00695684401251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, O2 MONITOR, DUAL, REFURBISHED
CAIRE INC.
AS099-4U
In Commercial Distribution

  • M766AS0994U0 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, O2 MONITOR, DUAL
CAIRE INC.
AS099-4
In Commercial Distribution

  • M766AS09940 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, REFURBISHED
CAIRE INC.
AS099-1U
In Commercial Distribution

  • M766AS0991U0 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, O2 MONITOR, REFURBISHED
CAIRE INC.
AS099-101U
In Commercial Distribution

  • M766AS099101U0 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, 02 MONITOR
CAIRE INC.
AS099-101
In Commercial Distribution

  • M766AS0991010 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, SINGLE, REFURBISHED
CAIRE INC.
AS099-100U
In Commercial Distribution

  • M766AS099100U0 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, SINGLE
CAIRE INC.
AS099-100
In Commercial Distribution

  • M766AS0991000 ()


  • Stationary oxygen concentrator
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