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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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2008® Series Hemodialysis Machines - 00840861100927

2008T GEN 2 BIBAG WITHOUT CDX
Fresenius Usa, Inc.
190895
In Commercial Distribution

  • 00840861100927 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100910

2008T HEMODIALYSIS SYSTEM W/CDX W/BIBAG
Fresenius Usa, Inc.
190766
In Commercial Distribution

  • 00840861100910 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100903

2008T HEMODIALYSIS SYSTEM WITHOUT CDX
Fresenius Usa, Inc.
190858
In Commercial Distribution

  • 00840861100903 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100897

2008T HEMODIALYSIS SYS., with CDX
Fresenius Usa, Inc.
190713
In Commercial Distribution

  • 00840861100897 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100873

2008K2 HEMO SYSTEM, OPTIONAL 5th MODULE
Fresenius Usa, Inc.
190633
In Commercial Distribution

  • 00840861100873 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100866

2008K2 MACHINE, SHORT CAB, OLC/DP, HP
Fresenius Usa, Inc.
190630
In Commercial Distribution

  • 00840861100866 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100859

2008K2 HEMODIALYSIS SYS. OLC/ DIASAFE PLS
Fresenius Usa, Inc.
190610
In Commercial Distribution

  • 00840861100859 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100965

2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
Fresenius Usa, Inc.
190904
In Commercial Distribution

  • 00840861100965 ()


  • Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines - 00840861100958

2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP
Fresenius Usa, Inc.
190395
In Commercial Distribution

  • 00840861100958 ()


  • Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines - 00840861100941

2008K@HOME HEMODIALYSIS SYSTEM
Fresenius Usa, Inc.
190828
In Commercial Distribution

  • 00840861100941 ()


  • Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines - 00840861100934

2008T HD SYSTEM WITH CDX, CANADA
Fresenius Usa, Inc.
190908
In Commercial Distribution

  • 00840861100934 ()


  • Haemodialysis system, institutional

Oxymixer Configuration - 04251411700935

Oxymixer blender configurable with blender Low Flow or High Flow blender version.
DEHAS Medical Systems GmbH
Configuration
In Commercial Distribution

  • 04251411700935 ()
MP04200

  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer Low Flow 15LPM - 04251411700928

Oxymixer blender Low Flow with 15LPM Flowmeter
DEHAS Medical Systems GmbH
Low Flow 15LPM
In Commercial Distribution

  • 04251411700928 ()
MP04229

  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer XL Low Flow - 04251411700775

Oxymixer XL blender Low Flow
DEHAS Medical Systems GmbH
XL Low Flow
In Commercial Distribution

  • 04251411700775 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer Low Flow SET - 04251411700027

Oxymixer blender Low Flow SET
DEHAS Medical Systems GmbH
Low Flow SET
In Commercial Distribution

  • 04251411700027 ()
MP04203

  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer High Flow SET - 04251411700010

Oxymixer blender High Flow SET
DEHAS Medical Systems GmbH
High Flow SET
In Commercial Distribution

  • 04251411700010 ()
MP04201

  • Oxygen/air/nitrous oxide breathing gas mixer

MXR Flow Meter assembly - 00816711020691

MXR Flow Meter assembly
PARKER-HANNIFIN CORPORATION
3066W
In Commercial Distribution

  • 00816711020691 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

INTL DMDM (STAND)-SPAIN - 00816711020677

INTL DMDM (STAND)-SPAIN
PARKER-HANNIFIN CORPORATION
40151602SPAIN
In Commercial Distribution

  • 00816711020677 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

MDM SPAIN MODEL - 00816711020660

MDM SPAIN MODEL
PARKER-HANNIFIN CORPORATION
94500150SPAIN
In Commercial Distribution

  • 00816711020660 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

MXR-1 FLUSH MTMUNIVER CAN - 00816711020653

MXR-1 FLUSH MTMUNIVER CAN
PARKER-HANNIFIN CORPORATION
C3065W
In Commercial Distribution

  • 00816711020653 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

E-BLOCK SUB ASSY & HOSES ISO - 00816711020639

E-BLOCK SUB ASSY & HOSES ISO - This is an accessory only; not a medical device
PARKER-HANNIFIN CORPORATION
C-1738-ISO
Not in Commercial Distribution

  • 00816711020639 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM - 00816711020417

DMDM BASIC ASSEMBLY,30 PCT
PARKER-HANNIFIN CORPORATION
40151601
In Commercial Distribution

  • 00816711020417 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

MXR FLOW METER - 00816711020356

MXR,FLOWMETER ASSEMBLY
PARKER-HANNIFIN CORPORATION
DTL-164W
In Commercial Distribution

  • 00816711020356 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

MXR-1 FLOW METER - 00816711020349

MXR-1, FLUSH MOUNT,UNIVERSAL FITTING, BACK, CAN15
PARKER-HANNIFIN CORPORATION
C3065W15
In Commercial Distribution

  • 00816711020349 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

MXR FLOW METER - 00816711020332

MXR,FLOWMETER ASSY 50% N2O MAX
PARKER-HANNIFIN CORPORATION
C3050
In Commercial Distribution

  • 00816711020332 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

ANALGESIA GAS MIXER, MDM DELIVERY SYSTEM - 00816711020264

MDM ASSEMBLY, INTERNATIONAL STANARD ISO
PARKER-HANNIFIN CORPORATION
94500150
In Commercial Distribution

  • 00816711020264 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM - 00816711020165

INTL DMDM BASIC ASSY,30 CANADA
PARKER-HANNIFIN CORPORATION
40151617
In Commercial Distribution

  • 00816711020165 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 70%-W-N2O, EAVS - 00816711024903

Midas Flowmeter, Portable, 70% Max, N2O Control+ eAVS
PARKER-HANNIFIN CORPORATION
6080-EAVS
In Commercial Distribution

  • 00816711024903 ()
6080-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 60%-W-N2O, EAVS - 00816711024897

Midas Flowmeter, Portable, 60% Max, N2O Control+ eAVS
PARKER-HANNIFIN CORPORATION
6070-EAVS
In Commercial Distribution

  • 00816711024897 ()
6070-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 50%-W-N2O, EAVS - 00816711024880

Midas Flowmeter, Portable, 50% Max, N2O Control+ eAVS
PARKER-HANNIFIN CORPORATION
6060-EAVS
In Commercial Distribution

  • 00816711024880 ()
6060-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 70%-W-O2 , EAVS - 00816711024873

Midas Flowmeter, Portable, 70% Max, O2 Control+ eAVS
PARKER-HANNIFIN CORPORATION
6050-EAVS
In Commercial Distribution

  • 00816711024873 ()
6050-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 60%-W-O2, EAVS - 00816711024866

Midas Flowmeter, Portable, 60% Max, O2 Control+ eAVS
PARKER-HANNIFIN CORPORATION
6040-EAVS
In Commercial Distribution

  • 00816711024866 ()
6040-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 50%-W-O2, EAVS - 00816711024859

Midas Flowmeter, Portable, 50% Max, O2 Control+ eAVS
PARKER-HANNIFIN CORPORATION
6030-EAVS
In Commercial Distribution

  • 00816711024859 ()
6030-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 60%-W-N2O SWE, EAVS - 00816711024842

Midas Flowmeter, Portable, 60% Max, N2O Control, Sweden+ eAVS
PARKER-HANNIFIN CORPORATION
6072-EAVS
In Commercial Distribution

  • 00816711024842 ()
6072-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 60%-W-O2 SWE , EAVS - 00816711024835

Midas Flowmeter, Portable, 60% Max, O2 Control, Sweden+ eAVS
PARKER-HANNIFIN CORPORATION
6042-EAVS
In Commercial Distribution

  • 00816711024835 ()
6042-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 70%-W-N2O AUS, EAVS - 00816711024828

Midas Flowmeter, Portable, 70% Max, N2O Control, Australia+ eAVS
PARKER-HANNIFIN CORPORATION
6081-EAVS
In Commercial Distribution

  • 00816711024828 ()
6081-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, PORT, 70%-W-O2 AUS, EAVS - 00816711024811

Midas Flowmeter, Portable, 70% Max, O2 Control, Australia+ eAVS
PARKER-HANNIFIN CORPORATION
6051-EAVS
In Commercial Distribution

  • 00816711024811 ()
6051-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, REM, 70%-W-N20 , EAVS - 00816711024804

Midas Flowmeter, Remote, 70% Max, N2O Control+ eAVS
PARKER-HANNIFIN CORPORATION
6180-EAVS
In Commercial Distribution

  • 00816711024804 ()
6180-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, REM, 60%-W-N2O, EAVS - 00816711024798

Midas Flowmeter, Remote, 60% Max, N2O Control+ eAVS
PARKER-HANNIFIN CORPORATION
6170-EAVS
In Commercial Distribution

  • 00816711024798 ()
6170-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer

MIDAS, REM, 50%-W-N2O, EAVS - 00816711024781

Midas Flowmeter, Remote, 50% Max, N2O Control+ eAVS
PARKER-HANNIFIN CORPORATION
6160-EAVS
In Commercial Distribution

  • 00816711024781 ()
6160-EAVS

  • Oxygen/air/nitrous oxide breathing gas mixer
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