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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BiPAP A30 Ventilator, Canada
Respironics, Inc.
BiPAP A30 Ventilator, CA
In Commercial Distribution

  • 00606959039339 ()
1111147

  • Portable electric ventilator
Dorma 500 Auto, Canada
Respironics, Inc.
Dorma 500 Auto, CA
In Commercial Distribution

  • 00606959038509 ()
501VCA

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar SE Auto CPAP System, Canada
Respironics, Inc.
REMstar SE Auto, CA
In Commercial Distribution

  • 00606959038417 ()
521CA

  • Home CPAP unit
  • Heated respiratory humidifier
Dorma 500 Auto, Canada
Respironics, Inc.
Dorma 500 Auto, CA
In Commercial Distribution

  • 00606959036734 ()
CAV501

  • Heated respiratory humidifier
  • Home CPAP unit
Millennium M10 Concentrator, Canada
Respironics, Inc.
Millennium M10 Concentrator, CA
In Commercial Distribution

  • 00606959033184 ()
M10600-80

  • Stationary oxygen concentrator
BiPAP Auto, BlueTooth, Canada
Respironics, Inc.
BiPAP Auto BlueTooth, CA
In Commercial Distribution

  • 00606959031753 ()
761CABT

  • Home BPAP unit
BiPAP Pro, Bluetooth, Canada
Respironics, Inc.
BiPAP Pro, Bluetooth, CA
In Commercial Distribution

  • 00606959031418 ()
661CABT

  • Home BPAP unit
DreamStation Auto BiPAP, Canada
Respironics, Inc.
DreamStation Auto BiPAP, CA
In Commercial Distribution

  • 00606959026643 ()
CAX700S12

  • Home BPAP unit
DreamStation BiPAP Pro, Canada
Respironics, Inc.
DreamStation BiPAP Pro, CA
In Commercial Distribution

  • 00606959026612 ()
CAX600S12

  • Home BPAP unit
DreamStation Auto CPAP, Canada
Respironics, Inc.
DreamStation Auto CPAP, CA
In Commercial Distribution

  • 00606959026582 ()
CAX500S12

  • Home CPAP unit
Electrocardiographic recording paper
GRAPHIC CONTROLS ACQUISITION CORP
HP M1911A (40/CA)
In Commercial Distribution

  • 50009336000598 ()
  • 00009336000593 ()
32016831

  • Electrocardiographic recording paper
Electrocardiographic recording paper
GRAPHIC CONTROLS ACQUISITION CORP
HP M1707A (8/CA)
In Commercial Distribution

  • 50009336000529 ()
  • 00009336000524 ()
30768678

  • Electrocardiographic recording paper
Electrocardiographic recording paper
GRAPHIC CONTROLS ACQUISITION CORP
CMS 4305 (40/CA)
In Commercial Distribution

  • 50009336000130 ()
  • 00009336000135 ()
30597226

  • Electrocardiographic recording paper
Bluetooth Accessory Module, Canada
Respironics, Inc.
Bluetooth Accessory Module, CA
Not in Commercial Distribution

  • 00606959005136 ()
100210B

  • Clinical laboratory information system
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution

  • 04260160470587 ()
201001

  • Coagulation analyser IVD, laboratory, semi-automated
S1 500 DT Dual CA 1150 1000 (Nml 3P SA, Dl Yoke 3P Lit) (Nl 3P SA, 3P Light)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007657 ()
C15D4333

  • Operating room light
S1 200 DT Dual CA 1150mm 1000mm (Nml 3P SA Dual YK 3P LT) Sgl MH - Sony Cvrt/Int
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007633 ()
C12D433N

  • Operating room light
S1 300 DT Dual CA 1150mm 1000mm (Nml 9P SA Dual YK 9P LT) Sgl MH - Sony Cvrt/Int
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007626 ()
C13D435N

  • Operating room light
S3 300 DT Dual CA 1000mm 850mm (Norm 3P SA Dl YK 3P LT)Sgl MH for Sony Mon.
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007534 ()
C33BDB323M

  • Operating room light
Series 1 300 DT Triple CA 1150 1000 850 Gen 1 3p sngl yoke x2 sngl M SA MH
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706001013 ()
C13T432FF1

  • Operating room light
S1 600 DT Dl CA 1300 1150 (Norm 9P SA Dual YK 9P Light),Gen2, Sgl M SA, MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007695 ()
C16D5451

  • Operating room light
S1 600 DT Dl CA 1300 1150 (Norm 3P SA Dual YK 3P Light),Gen2, Sgl M SA, MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007688 ()
C16D5431

  • Operating room light
Series 3 300 DT sgl dual sgl CA 1300/1300/1150/1000 2x MH 1xDY 30M 1x 4K 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007152 ()
C33SDS554311S3

  • Operating room light
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 450 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044345010
In Commercial Distribution

  • 08426951070800 ()
00044345010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 300 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044330010
In Commercial Distribution

  • 08426951070794 ()
00044330010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 150 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044315010
In Commercial Distribution

  • 08426951070787 ()
00044315010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 75 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044307510
In Commercial Distribution

  • 08426951070770 ()
00044307510

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Foam Positioner Prone and Lateral Head Large Polyurethane Foam White CA/10 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49506
In Commercial Distribution

  • 20885632444668 ()
  • 10885632444661 ()


  • Freestanding headrest, single-use
Foam Positioner Prone and Lateral Head Small Polyurethane Foam White CA/10 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49505
In Commercial Distribution

  • 20885632444651 ()
  • 10885632444654 ()


  • Freestanding headrest, single-use
Rigid Container Sterilization 9x0.5x9 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58161
In Commercial Distribution

  • 10885632436079 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 28x11x3 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58157
In Commercial Distribution

  • 10885632436031 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 18x11x8 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58067
In Commercial Distribution

  • 10885632436024 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 11.5x11x6 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58135
In Commercial Distribution

  • 10885632436017 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 11.5x11x5 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58134
In Commercial Distribution

  • 10885632436000 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 28x11x8 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58156
In Commercial Distribution

  • 10885632435997 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 28x11x8 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58145
In Commercial Distribution

  • 10885632435980 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 11.5x11x3 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58139
In Commercial Distribution

  • 10885632435973 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 11.5x11x10 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58138
In Commercial Distribution

  • 10885632435966 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 11.5x11x8 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58136
In Commercial Distribution

  • 10885632435959 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 11.5x11x4 Aluminum Alloy Stainless Steel Silicone Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58098
In Commercial Distribution

  • 10885632435942 ()


  • Device sterilization/disinfection container, reusable
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