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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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Hyperbaric Chamber
Hyperbaric For Life.com, Llc
8003
In Commercial Distribution

  • G625R800340 ()


  • Hyperbaric chamber, stationary
The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi-rigid chamber for low pressures (operating at pressures of no greater than 1.5 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012).
US Hyperbaric Network LLC
430+
In Commercial Distribution

  • G623430 ()


  • Hyperbaric chamber, stationary
Diana Peristaltic Pump
ICU MEDICAL, INC.
DS1000
In Commercial Distribution

  • 00840619099046 ()
DS1000

  • Pharmaceutical fluid-dispensing system
Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5300R
In Commercial Distribution

  • 00840619091590 ()
CL5300R

  • Pharmaceutical fluid-dispensing system
Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5000
In Commercial Distribution

  • 00840619090876 ()
CL5000

  • Pharmaceutical fluid-dispensing system
Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5300
In Commercial Distribution

  • 00840619089894 ()
CL5300

  • Pharmaceutical fluid-dispensing system
Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CH5000R
In Commercial Distribution

  • 00840619065058 ()
CH5000R

  • Pharmaceutical fluid-dispensing system
Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CH5000
In Commercial Distribution

  • 00840619054908 ()
CH5000

  • Pharmaceutical fluid-dispensing system
MULTI-AD® Transfer Set (MAT4100)
B. BRAUN MEDICAL INC.
513548
In Commercial Distribution

  • 04022495818348 ()
  • 04045928016357 ()
513548

  • Pharmaceutical fluid-dispensing system
MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513540
In Commercial Distribution

  • 04022495770400 ()
  • 04022495871213 ()
513540

  • Pharmaceutical fluid-dispensing system
MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513506
In Commercial Distribution

  • 04022495770394 ()
  • 04046963093099 ()
513506

  • Pharmaceutical fluid-dispensing system
MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513501
In Commercial Distribution

  • 04022495770387 ()
  • 04046964189708 ()
513501

  • Pharmaceutical fluid-dispensing system
Motion Mobile DR Retrofit Kit
CARESTREAM HEALTH, INC.
CARESTREAM DRX-Mobile Retrofit Kit
Not in Commercial Distribution

  • 60889971740366 ()
1740364

  • Diagnostic x-ray digital imaging conversion system
FLAT TAPE ON GRID FOR 25X30 DETECTOR
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System Detector
In Commercial Distribution

  • 60889971054968 ()
1054964

  • Diagnostic x-ray digital imaging conversion system
THL 4143C CsI High Resolution Digital Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN261
In Commercial Distribution

  • 00817100020308 ()


  • Diagnostic x-ray digital imaging conversion system
THL 3543EZ CsI Digital Wireless Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN280
In Commercial Distribution

  • 00817100020285 ()


  • Diagnostic x-ray digital imaging conversion system
IR 14X17 Portable GOS Flat Panel Detector without USB (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN241
In Commercial Distribution

  • 00817100020247 ()


  • Diagnostic x-ray digital imaging conversion system
IR 14X17 Portable GOS Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN240
In Commercial Distribution

  • 00817100020230 ()


  • Diagnostic x-ray digital imaging conversion system
IR 17X17 GOS Fixed Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN221
In Commercial Distribution

  • 00817100020223 ()


  • Diagnostic x-ray digital imaging conversion system
IR 17X17 CsI Fixed Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN220
In Commercial Distribution

  • 00817100020216 ()


  • Diagnostic x-ray digital imaging conversion system
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