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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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KMI IMI GROUP - 00851314007113

Handles & Adaptors
Innovative Med
19-0092
In Commercial Distribution

  • 00851314007113 ()


  • Liposuction system cannula, reusable
  • Collection syringe adaptor, reusable

ACE - 00614950013449

ACE TWO WAY PLASTIC AUTOMATIC VALVE STERILE DISP L/F 10/PKG
ACE SURGICAL SUPPLY CO., INC.
0031156
In Commercial Distribution

  • 00614950013449 ()
  • 10614950013446 ()
0031156

  • Mechanical expiratory valve, single-use

PIXELCHART PC-50S for COMPU VISION CV-5000 - 04571130283084

No Description
TOPCON CORPORATION
PC-50S
In Commercial Distribution

  • 04571130283084 ()


  • Visual acuity light box

MIRROR CHART MC-5S for COMPU VISION CV-5000 - 04571130283060

No Description
TOPCON CORPORATION
MC-5S
In Commercial Distribution

  • 04571130283060 ()


  • Visual acuity light box

Valve, Bleed Tail - 00709078010705

Valve, Bleed Tail, Bulk(100/Cs)
WESTMED, INC.
7-00675
In Commercial Distribution

  • 00709078010705 ()
  • 10709078010719 ()


  • Mechanical expiratory valve, single-use

WaterPAP PRO - 00862146000319

No Description
AIRWAYS DEVELOPMENT COMPANY LLC
WP-7800
In Commercial Distribution

  • 40862146000300 ()
  • 30862146000303 ()
  • 00862146000319 ()


  • Mechanical expiratory valve, single-use

WaterPAP - 00862146000302

Positive Airway pressure device
AIRWAYS DEVELOPMENT COMPANY LLC
WP-7700
In Commercial Distribution

  • 20862146000306 ()
  • 10862146000309 ()
  • 00862146000302 ()


  • Mechanical expiratory valve, single-use

HeliO2 Blender - 00855887006054

PM5400 SERIES,BLENDER,HE/O2,LOW FLOW,80/20
Precision Medical, Inc.
PM5480
In Commercial Distribution

  • 00855887006054 ()


  • Helium/oxygen breathing gas mixer

HeliO2 Blender - 00855887006047

PM5400 SERIES,BLENDER,HE/O2,LOW FLOW,70/30
Precision Medical, Inc.
PM5470
In Commercial Distribution

  • 00855887006047 ()


  • Helium/oxygen breathing gas mixer

HeliO2 Blender - 00855887006030

PM5500 SERIES,BLENDER,HE/O2,HIGH FLOW,70/30
Precision Medical, Inc.
PM5570
In Commercial Distribution

  • 00855887006030 ()


  • Helium/oxygen breathing gas mixer

HeliO2 Blender - 00855887006023

PM5500 SERIES,BLENDER,HE/O2,HIGH FLOW,80/20
Precision Medical, Inc.
PM5580
In Commercial Distribution

  • 00855887006023 ()


  • Helium/oxygen breathing gas mixer

Visionix - 03664188000251

Chart Display
LUNEAU TECHNOLOGY OPERATIONS
VX22-CP
In Commercial Distribution

  • 03664188000251 ()


  • Visual acuity light box

Visionix - 03664188000244

Chart Display
LUNEAU TECHNOLOGY OPERATIONS
VX22-LP
In Commercial Distribution

  • 03664188000244 ()


  • Visual acuity light box

Visionix - 03664188000237

Chart Display
LUNEAU TECHNOLOGY OPERATIONS
VX22-NP
In Commercial Distribution

  • 03664188000237 ()


  • Visual acuity light box

Visionix - 03664188000152

Chart Display
LUNEAU TECHNOLOGY OPERATIONS
VX22
In Commercial Distribution

  • 03664188000152 ()


  • Visual acuity light box

FloWire Doppler Guide Wire XT 300cm 014 JTIP - 00184360000204

No Description
VOLCANO CORPORATION
1413J
In Commercial Distribution

  • 00184360000204 ()


  • Blood flowmeter catheter, Doppler

FloWire Doppler Guide Wire XT 300cm 014 ST - 00184360000198

No Description
VOLCANO CORPORATION
1413
In Commercial Distribution

  • 00184360000198 ()


  • Blood flowmeter catheter, Doppler

FloWire Doppler Guide Wire XT 175cm 014 JTIP - 00184360000167

No Description
VOLCANO CORPORATION
1403J
In Commercial Distribution

  • 00184360000167 ()


  • Blood flowmeter catheter, Doppler

FloWire Doppler Guide Wire - 00184360000150

No Description
Philips Image Guided Therapy Corporation
1403
In Commercial Distribution

  • 00184360000150 ()
1403

  • Blood flowmeter catheter, Doppler

FloWire Doppler Guide Wire - 00184360000129

No Description
Philips Image Guided Therapy Corporation
1400J
In Commercial Distribution

  • 00184360000129 ()
1400J

  • Blood flowmeter catheter, Doppler
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