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
Mixing Tips 48 x MIXING TIPS INJECTION NDS PINK
Gc America Inc.
153148
In Commercial Distribution

  • 00386040006180 ()
  • 10386040006187 ()
153148

  • Pharmaceutical fluid-dispensing system
Mixing Tips 48 x MIXING TIPS HEAVY NDS PURPLE
Gc America Inc.
153048
In Commercial Distribution

  • 00386040006173 ()
  • 10386040006170 ()
153048

  • Pharmaceutical fluid-dispensing system
Mixing Tips 12 x MIXING TIPS AQUA TYPE 2L NDS
Gc America Inc.
153012
In Commercial Distribution

  • 00386040006166 ()
  • 10386040006163 ()
153012

  • Pharmaceutical fluid-dispensing system
GC CARTRIDGE DISPENSER II Plunger Conversion Kit, 75mL
Gc America Inc.
152171
In Commercial Distribution

  • 10386040006156 ()
152171

  • Pharmaceutical fluid-dispensing system
GC CARTRIDGE DISPENSER II Plunger, 48mL
Gc America Inc.
152161
In Commercial Distribution

  • 10386040006149 ()
152161

  • Pharmaceutical fluid-dispensing system
GC CARTRIDGE DISPENSER II 75mL
Gc America Inc.
152102
In Commercial Distribution

  • 10386040006132 ()
152102

  • Pharmaceutical fluid-dispensing system
EXA’lence™ Accessories GC Intra-Oral Tips, 100pcs
Gc America Inc.
150300
In Commercial Distribution

  • 00386040006128 ()
  • 10386040006125 ()
150300

  • Pharmaceutical fluid-dispensing system
PLUNGER FOR UNIVERSAL DISPENSER
Gc America Inc.
152081
In Commercial Distribution

  • 10386040012393 ()
152081

  • Pharmaceutical fluid-dispensing system
COE ADHESIVE Bulk Pkg - 12 Btls
Gc America Inc.
133912
In Commercial Distribution

  • 10386040004992 ()
133912

  • Pharmaceutical fluid-dispensing system
COE® ADHESIVE BOTTLE ONLY, 13mL
Gc America Inc.
133911
In Commercial Distribution

  • 10386040004985 ()
133911

  • Pharmaceutical fluid-dispensing system
GC CARTRIDGE DISPENSER II 48mL
Gc America Inc.
152101
In Commercial Distribution

  • 10386040004107 ()
152101

  • Pharmaceutical fluid-dispensing system
The FLAATZ 560 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 560
In Commercial Distribution

  • 08800018403808 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 600 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 600
In Commercial Distribution

  • 08800018402405 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 750E detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 750E
In Commercial Distribution

  • 08800018404102 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 500 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 500
In Commercial Distribution

  • 08800018404003 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 760 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 760
In Commercial Distribution

  • 08800018403907 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 601 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 601
In Commercial Distribution

  • 08800018402504 ()


  • Diagnostic x-ray digital imaging conversion system
ESP-60cc version
ICU MEDICAL, INC.
ESP-60S
In Commercial Distribution

  • 00887709082717 ()
ESP-60S

  • Pharmaceutical fluid-dispensing system
Diana Web Server Software
ICU MEDICAL, INC.
DS2800-04-01
In Commercial Distribution

  • 00887709126770 ()
DS2800-04-01

  • Pharmaceutical fluid-dispensing system
Diana Workflow Management Software
ICU MEDICAL, INC.
DS2110-04-01
In Commercial Distribution

  • 00887709126749 ()
DS2110-04-01

  • Pharmaceutical fluid-dispensing system
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