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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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PressureGuard® - H9338300

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

  • H9338300 ()
8300

  • Alternating-pressure inflator

PressureGuard® - H9337500

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

  • H9337500 ()
7500

  • Alternating-pressure inflator

InQwire® - 00884450029039

No Description
Merit Medical Systems, Inc.
00884450029039
In Commercial Distribution

  • 20884450029033 ()
  • 10884450029036 ()
  • 00884450029039 ()

  • Tip Shape-Straight Tip
  • Configuration-Super Stiff Exchange
  • Length-260 cm (102")


  • Cardiac/peripheral vascular guidewire, single-use

InQwire® - 00884450027226

No Description
Merit Medical Systems, Inc.
00884450027226
In Commercial Distribution

  • 10884450027223 ()
  • 00884450027226 ()
  • 20884450027220 ()

  • Length-260 cm (102")
  • Tip Shape-1.5 mm J-Tip
  • Configuration-Rosen Exchange
6609-33/A

  • Cardiac/peripheral vascular guidewire, single-use

InQwire® - 00884450024065

No Description
Merit Medical Systems, Inc.
00884450024065
In Commercial Distribution

  • 10884450024062 ()
  • 00884450024065 ()
  • 20884450024069 ()

  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Tip Shape-3 mm J-Tip


  • Cardiac/peripheral vascular guidewire, single-use

Exchange CO2 Sensor, NICO C3 - 00884838033870

No Description
Respironics Novametrix, LLC
00
In Commercial Distribution

  • 00884838033870 ()
U9567-37

  • Patient monitoring system module, carbon dioxide

LMA AIRWAY MANAGEMENT - 05060112310430

LMA Fastrach™ Stabiliser Rod
TELEFLEX INCORPORATED
IPN901829
In Commercial Distribution

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

  • Endotracheal tube stabilization rod

LMA AIRWAY MANAGEMENT - 25060112314739

LMA Fastrach™ Stabiliser Rod
TELEFLEX INCORPORATED
IPN915395
In Commercial Distribution

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

  • Endotracheal tube stabilization rod

NA - 06974599110485

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

Bio30+ Physio Accelerated - 05056336800208

Ion exchange chromatography analyzer sold with lithium accelerated column and autosampler.
BIOCHROM LIMITED
80-6000-51
In Commercial Distribution

  • 05056336800208 ()


  • Amino acid analyser IVD

MEDADV - 00819667020852

ENCOURAGE PTCA BALLOON CATHETER 3.0 mm X 20 mm RAPID EXCHANGE
MEDAS INC
M92130020
In Commercial Distribution

  • 00819667020852 ()
M92130020

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020623

ENCOURAGE PTCA BALLOON CATHETER 3.0 mm X 26 mm RAPID EXCHANGE
MEDAS INC
M92130026
In Commercial Distribution

  • 00819667020623 ()
M92130026

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020609

ENCOURAGE PTCA BALLOON CATHETER 2.75 mm X 26 mm RAPID EXCHANGE
MEDAS INC
M92127026
In Commercial Distribution

  • 00819667020609 ()
M92127026

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020593

ENCOURAGE PTCA BALLOON CATHETER 2.75 mm X 20 mm RAPID EXCHANGE
MEDAS INC
M92127020
In Commercial Distribution

  • 00819667020593 ()
M92127020

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020548

ENCOURAGE PTCA BALLOON CATHETER 2.0 mm X 18 mm RAPID EXCHANGE
MEDAS INC
M92120018
In Commercial Distribution

  • 00819667020548 ()
M92120018

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020531

ENCOURAGE PTCA BALLOON CATHETER 2.0 mm X 16 mm RAPID EXCHANGE
MEDAS INC
M92120016
In Commercial Distribution

  • 00819667020531 ()
M92120016

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020500

ENCOURAGE PTCA BALLOON CATHETER 1.75 mm X 18 mm RAPID EXCHANGE
MEDAS INC
M92117018
In Commercial Distribution

  • 00819667020500 ()
M92117018

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020494

ENCOURAGE PTCA BALLOON CATHETER 1.75 mm X 16 mm RAPID EXCHANGE
MEDAS INC
M92117016
In Commercial Distribution

  • 00819667020494 ()
M92117016

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020487

ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 20 mm RAPID EXCHANGE
MEDAS INC
M92115020
In Commercial Distribution

  • 00819667020487 ()
M92115020

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020470

ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 18 mm RAPID EXCHANGE
MEDAS INC
M92115018
In Commercial Distribution

  • 00819667020470 ()
M29115018

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020463

ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 16 mm RAPID EXCHANGE
MEDAS INC
M92115016
In Commercial Distribution

  • 00819667020463 ()
M92115016

  • Coronary angioplasty balloon catheter, basic

MEDADV - 00819667020456

ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 12 mm RAPID EXCHANGE
MEDAS INC
M92115012
In Commercial Distribution

  • 00819667020456 ()
M92115012

  • Coronary angioplasty balloon catheter, basic

Symetrex - M967R20033

Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 33 cm
Phase One Medical LLC
R20033
In Commercial Distribution

  • M967R20033 ()

  • Catheter Gauge: 15.5 French
  • Length: 33 Centimeter
R20033

  • Double-lumen haemodialysis catheter, implantable

Symetrex - M967R20028

Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 28 cm
Phase One Medical LLC
R20028
In Commercial Distribution

  • M967R20028 ()

  • Catheter Gauge: 15.5 French
  • Length: 28 Centimeter
R20028

  • Double-lumen haemodialysis catheter, implantable

Symetrex - M967R20023

Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 23 cm
Phase One Medical LLC
R20023
In Commercial Distribution

  • M967R20023 ()

  • Catheter Gauge: 15.5 French
  • Length: 23 Centimeter
R20023

  • Double-lumen haemodialysis catheter, implantable

Symetrex - M967R20019

Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 19 cm
Phase One Medical LLC
R20019
In Commercial Distribution

  • M967R20019 ()

  • Catheter Gauge: 15.5 French
  • Length: 19 Centimeter
R20019

  • Double-lumen haemodialysis catheter, implantable

SYMETREX TM - 00884908126402

15.5F X 33CM SYMETREX KIT (CUFF 33CM FROM TIP) EXCHANGE KIT
Medical Components, Inc.
MR20033
Not in Commercial Distribution

  • 50884908126407 ()
  • 00884908126402 ()


  • Double-lumen haemodialysis catheter, implantable

SYMETREX TM - 00884908126396

15.5F X 28CM SYMETREX KIT (CUFF 28CM FROM TIP) EXCHANGE KIT
Medical Components, Inc.
MR20028
Not in Commercial Distribution

  • 50884908126391 ()
  • 00884908126396 ()


  • Double-lumen haemodialysis catheter, implantable

SYMETREX TM - 00884908126372

15.5F X 19CM SYMETREX KIT (CUFF 19CM FROM TIP) EXCHANGE KIT
Medical Components, Inc.
MR20019
Not in Commercial Distribution

  • 50884908126377 ()
  • 00884908126372 ()


  • Double-lumen haemodialysis catheter, implantable

SYMETREX TM - 00884908126389

15.5F X 23CM SYMETREX KIT (CUFF 23CM FROM TIP) EXCHANGE KIT
Medical Components, Inc.
MR20023
Not in Commercial Distribution

  • 50884908126384 ()
  • 00884908126389 ()


  • Double-lumen haemodialysis catheter, implantable

NA - 04055207010679

STERILE ADAPTER Plug-eyepiece for endoscope exchange under sterile conditions, lock mechanism
Richard Wolf GmbH
858091
Not in Commercial Distribution

  • 04055207010679 ()

  • Length: 40 Millimeter
8580.91

  • Endoscope camera adaptor

HS Glove - 09551012690143

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035WHT240F (M)
In Commercial Distribution

  • 09551012690143 ()
  • 09551012690747 ()


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

HS Glove - 09551012690136

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035WHT240F (S)
In Commercial Distribution

  • 09551012690136 ()
  • 09551012690730 ()


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

HS Glove - 09551012690129

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035WHT240F (XS)
In Commercial Distribution

  • 09551012690129 ()
  • 09551012690723 ()


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

HS Glove - 09551012690112

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035BLK240F (XXL)
In Commercial Distribution

  • 09551012690112 ()
  • 09551012690716 ()


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

HS Glove - 09551012690105

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035BLK240F (XL)
In Commercial Distribution

  • 09551012690105 ()
  • 09551012690709 ()


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

HS Glove - 09551012690099

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035BLK240F (L)
In Commercial Distribution

  • 09551012690099 ()
  • 09551012690693 ()


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

HS Glove - 09551012690082

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035BLK240F (M)
In Commercial Distribution

  • 09551012690082 ()
  • 09551012690686 ()


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

HS Glove - 09551012690075

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035BLK240F (S)
In Commercial Distribution

  • 09551012690075 ()
  • 09551012690679 ()


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

HS Glove - 09551012690068

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035BLK240F (XS)
In Commercial Distribution

  • 09551012690068 ()
  • 09551012690662 ()


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

HS Glove - 09551012690051

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035RGB240F (XXL)
In Commercial Distribution

  • 09551012690051 ()
  • 09551012690655 ()


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

HS Glove - 09551012690044

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035RGB240F (XL)
In Commercial Distribution

  • 09551012690044 ()
  • 09551012690648 ()


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

HS Glove - 09551012690037

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035RGB240F (L)
In Commercial Distribution

  • 09551012690037 ()
  • 09551012690631 ()


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

HS Glove - 09551012690020

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035RGB240F (M)
In Commercial Distribution

  • 09551012690020 ()
  • 09551012690624 ()


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

HS Glove - 09551012690013

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035RGB240F (S)
In Commercial Distribution

  • 09551012690013 ()
  • 09551012690617 ()


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

HS Glove - 09551012690006

Powder Free Nitrile Examination Glove
HONG SENG GLOVES SDN. BHD.
A035RGB240F (XS)
In Commercial Distribution

  • 09551012690006 ()
  • 09551012690600 ()


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

HS Glove - 09551012690174

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

HS Glove - 09551012690167

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

HS Glove - 09551012690150

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

Bio30+ Physiological HR - 05056336800277

Ion exchange chromatography analyzer sold with lithium high resolution column and autosampler.
BIOCHROM LIMITED
80-6000-57
In Commercial Distribution

  • 05056336800277 ()


  • Amino acid analyser IVD
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