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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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AltaDyne XT Alternating Pressure/Low Air Loss Pump
GF HEALTH PRODUCTS, INC.
774200AP
In Commercial Distribution

  • M368774200AP2 ()
  • M368774200AP1 ()


  • Alternating-pressure inflator
Clinical Sensor Plus Alternating Pressure Pump
GF HEALTH PRODUCTS, INC.
765000SP
In Commercial Distribution

  • M368765000SP2 ()
  • M368765000SP1 ()


  • Alternating-pressure inflator
Clinical Plus Alternating Pressure/Low Air Loss Pump
GF HEALTH PRODUCTS, INC.
760000SP
In Commercial Distribution

  • M368760000SP2 ()
  • M368760000SP1 ()


  • Alternating-pressure inflator
AltaDyne Alternating Pressure/Low Air Loss Pump
GF HEALTH PRODUCTS, INC.
750000P
In Commercial Distribution

  • M368750000P2 ()
  • M368750000P1 ()


  • Alternating-pressure inflator
Hospital Bed Surface
HILL-ROM, INC.
PCU4
In Commercial Distribution

  • 00887761017030 ()


  • Alternating-pressure inflator
Hospital Bed Surface
HILL-ROM, INC.
PCU2
In Commercial Distribution

  • 00887761001183 ()


  • Alternating-pressure inflator
Hospital Bed Surface
HILL-ROM, INC.
PCU1
In Commercial Distribution

  • 00887761001176 ()


  • Alternating-pressure inflator
Hospital Bed Surface
HILL-ROM, INC.
P005787RENT02
In Commercial Distribution

  • 00887761001022 ()


  • Alternating-pressure inflator
Hospital Bed Surface
HILL-ROM, INC.
P005723CAP02
In Commercial Distribution

  • 00887761001015 ()


  • Alternating-pressure inflator
CONTROL UNIT, DOLPHIN PED., EUR, JOERNS
JOERNS HEALTHCARE, LLC
DLPP-OOOOOOEUJ-CU
In Commercial Distribution

  • 00810055880997 ()


  • Alternating-pressure inflator
CONTROL UNIT, DOLPHIN PED., UK JOERNS
JOERNS HEALTHCARE, LLC
DLPP-OOOOOOUKJ-CU
In Commercial Distribution

  • 00810055880980 ()


  • Alternating-pressure inflator
CONTROL UNIT,DOLPHIN,SWISS,JOERNS
JOERNS HEALTHCARE, LLC
DLPH-OOOOOOSWJ-CU
In Commercial Distribution

  • 00810055880973 ()


  • Alternating-pressure inflator
CONTROL UNIT DOLPHIN AUSTRALIAN JOERNS
JOERNS HEALTHCARE, LLC
DLPH-OOOOOOAUJ-CU
In Commercial Distribution

  • 00810055880966 ()


  • Alternating-pressure inflator
CONTROL UNIT, DOLPHIN, UK, JOERNS
JOERNS HEALTHCARE, LLC
DLPH-OOOOOOUKJ-CU
In Commercial Distribution

  • 00810055880959 ()


  • Alternating-pressure inflator
CONTROL UNIT, DOLPHIN, EUR, JOERNS
JOERNS HEALTHCARE, LLC
DLPH-OOOOOOEUJ-CU
In Commercial Distribution

  • 00810055880942 ()


  • Alternating-pressure inflator
CONTROL UNIT, PROMATT ATA, UK
JOERNS HEALTHCARE, LLC
PMPUK-ES
In Commercial Distribution

  • 00810055880904 ()


  • Alternating-pressure inflator
Lumex Select Convertible Mattress Pump
GF HEALTH PRODUCTS, INC.
LCMP100
In Commercial Distribution

  • M368LCMP1001 ()


  • Alternating-pressure inflator
Alternating Pressure Mattress Control Unit
SPAN-AMERICA MEDICAL SYSTEMS, INC.
APM
Not in Commercial Distribution

  • H93338034 ()
38034

  • Alternating-pressure inflator
Alternating Pressure Mattress Control Unit
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Easy Air XL
Not in Commercial Distribution

  • H9338300 ()
8300

  • Alternating-pressure inflator
Alternating Pressure Mattress Control Unit
SPAN-AMERICA MEDICAL SYSTEMS, INC.
APM Bariatric
Not in Commercial Distribution

  • H9337500 ()
7500

  • Alternating-pressure inflator
MEM 84 X 48 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
Not in Commercial Distribution

  • H933MEM8448CEI0 ()
MEM8448CEI

  • Alternating-pressure inflator
MEM 84 X 42 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
Not in Commercial Distribution

  • H933MEM8442CEI0 ()
MEM8442CEI

  • Alternating-pressure inflator
MEM 84 X 36 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
Not in Commercial Distribution

  • H933MEM8436CEI0 ()
MEM8436CEI

  • Alternating-pressure inflator
MEM 80 X 60 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
Not in Commercial Distribution

  • H933MEM8060CEI0 ()
MEM8060CEI

  • Alternating-pressure inflator
MEM 80 X 54 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
Not in Commercial Distribution

  • H933MEM8054CEI0 ()


  • Alternating-pressure inflator
MEM 80 X 48 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
Not in Commercial Distribution

  • H933MEM48CEI0 ()
MEM48CEI

  • Alternating-pressure inflator
MEM 80 X 36 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
Not in Commercial Distribution

  • H933MEM36CEI0 ()
MEM36CEI

  • Alternating-pressure inflator
No Description
Merit Medical Systems, Inc.
00884450239803
In Commercial Distribution

  • 10884450239800 ()
  • 00884450239803 ()
  • 20884450239807 ()

  • Tip Shape-Straight Short (1.0 cm) Tip
  • Configuration-Amplatz Exchange
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange; Tip Shape-Straight Short (1.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102")
  • Length-260 cm (102"); Tip Shape-Straight Short (1.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102")
IQA509

  • Cardiac/peripheral vascular guidewire, single-use
No Description
Merit Medical Systems, Inc.
00884450239773
In Commercial Distribution

  • 10884450239770 ()
  • 00884450239773 ()
  • 20884450239777 ()

  • Tip Shape-Straight Short (1.0 cm) Tip
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange
  • Configuration-Amplatz Exchange; Tip Shape-Straight Short (1.0 cm) Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
  • Length-260 cm (102"); Tip Shape-Straight Short (1.0 cm) Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
IQA510

  • Cardiac/peripheral vascular guidewire, single-use
Ion exchange chromatography analyzer sold with lithium high resolution column.
BIOCHROM LIMITED
80-6000-58
In Commercial Distribution

  • 05056336800284 ()


  • Amino acid analyser IVD
Ion exchange chromatography analyzer sold with lithium high performance column.
BIOCHROM LIMITED
80-6000-55
In Commercial Distribution

  • 05056336800253 ()


  • Amino acid analyser IVD
1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US
GENTUITY LLC
US Catheter Kit G30-01
In Commercial Distribution

  • 00859910007018 ()

  • Catheter Gauge: 1.8 French


  • Coronary optical coherence tomography system catheter
TFE Coated Curved Amplatz Ultra Stiff Wire Guide - Catheter Exchange
COOK INCORPORATED
G20320
In Commercial Distribution

  • 00827002203204 ()
THSCF-35-260-3-AUS2

  • Peripheral vascular guidewire, manual
Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.
LIFESTYLE CO INC, THE
MS0610/H
Not in Commercial Distribution

  • 00830002000056 ()


  • Contact lens agitation cleaning system, mechanical
LMA Fastrach™ Stabiliser Rod
TELEFLEX INCORPORATED
IPN901829
In Commercial Distribution

  • 15060112310437 ()
  • 05060112310430 ()
  • 25060112310434 ()
130099

  • Endotracheal tube stabilization rod
This device helps to hold the endotracheal tube in position when exchanging a in situ laryngeal mask after endotracheal tube is in place.
Changsha Magill Medical Technology Co., Ltd.
EJT-1
Not in Commercial Distribution

  • 86974599110481 ()
  • 06974599110485 ()


  • Endotracheal tube stabilization rod
LMA Fastrach™ Stabiliser Rod
TELEFLEX INCORPORATED
IPN915395
In Commercial Distribution

  • 45060112314733 ()
  • 35060112314736 ()
  • 25060112314739 ()
  • 15060112314732 ()
130099

  • Endotracheal tube stabilization rod
Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035WHT240F (XXL)
In Commercial Distribution

  • 09551012690174 ()
  • 09551012690778 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035WHT240F (XL)
In Commercial Distribution

  • 09551012690167 ()
  • 09551012690761 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035WHT240F (L)
In Commercial Distribution

  • 09551012690150 ()
  • 09551012690754 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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