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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

FloWire Doppler Guide Wire - 00184360000112

No Description
Philips Image Guided Therapy Corporation
1400
In Commercial Distribution

  • 00184360000112 ()
1400

  • Blood flowmeter catheter, Doppler

Cook-Swartz - 00827002213630

Cook-Swartz Doppler Flow Probe Standard Cuff
Cook Vandergrift Inc.
G21363
In Commercial Distribution

  • 00827002213630 ()
  • 10827002213637 ()
DP-SDP001

  • Blood flowmeter catheter, Doppler

Cook-Swartz - 00827002030145

Cook-Swartz Doppler Flow Probe Long Cuff
Cook Vandergrift Inc.
G03014
In Commercial Distribution

  • 00827002030145 ()
  • 10827002030142 ()
DP-SDP002

  • Blood flowmeter catheter, Doppler

Visual Chart System - 08800074500299

CSPOLA600C is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600C can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600C is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600C
In Commercial Distribution

  • 08800074500299 ()
CSPOLA600C

  • Visual acuity light box

LCD ACUITY DEVICE - 08800074500152

PROVUE is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for PROVUE can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, PROVUE is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
PROVUE
In Commercial Distribution

  • 08800074500152 ()
PROVUE

  • Visual acuity light box

Visual Chart System - 08800074500114

CSPOLA600 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600
In Commercial Distribution

  • 08800074500114 ()
CSPOLA600

  • Visual acuity light box

Visual Chart System - 08800074500046

No Description
VIEW-M TECHNOLOGY CO., LTD.
SCS-3200
In Commercial Distribution

  • 08800074500046 ()
SCS-3200

  • Visual acuity light box

Visual Chart System - 08800074500022

VLC-2400 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-2400
In Commercial Distribution

  • 08800074500022 ()
VLC-2400

  • Visual acuity light box

Visual Chart System - 08800074500015

VLC-1900P is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-1900P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900P is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-1900P
In Commercial Distribution

  • 08800074500015 ()
VLC-1900P

  • Visual acuity light box

Visual Chart System - 08800074500305

CSPOLA600F is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600F can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600F is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600F
In Commercial Distribution

  • 08800074500305 ()
CSPOLA600F

  • Visual acuity light box

Visual Chart System - 08800074500282

CS550 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CS550 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CS550 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CS550
In Commercial Distribution

  • 08800074500282 ()
CS550

  • Visual acuity light box

Visual Chart System - 08800074500039

VLC-2400P is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400P is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-2400P
In Commercial Distribution

  • 08800074500039 ()
VLC-2400P

  • Visual acuity light box

Visual Chart System - 08800074500008

VLC-1900 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-1900 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-1900
In Commercial Distribution

  • 08800074500008 ()
VLC-1900

  • Visual acuity light box

Vision-C 600 - 03615020000670

Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
ESSILOR INTERNATIONAL
VRS001
In Commercial Distribution

  • 03615020000670 ()


  • Visual acuity light box

WaterPAP PRO Starter Kit - 90862146000336

WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole Clamp, Instructions for use.
AIRWAYS DEVELOPMENT COMPANY LLC
WP-7805
In Commercial Distribution

  • 90862146000336 ()


  • Mechanical expiratory valve, single-use

WaterPAP Starter Kit - 90862146000329

WaterPAP Starter Kit consists of 4 WaterPAP canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole clamp, Instructions for use
AIRWAYS DEVELOPMENT COMPANY LLC
WP-7705
In Commercial Distribution

  • 90862146000329 ()


  • Mechanical expiratory valve, single-use

AincA - B00500379S0

Evacuator, Gas, In-line, w/Pop-Off, 15mmM x 15mmF x 1/4" Nipple x 19mmM Suction w/Neg Relief, Delrin
ANESTHESIA ASSOCIATES, INC.
00-379-S
In Commercial Distribution

  • B00500379S0 ()
00-379-S

  • Mechanical expiratory valve, reusable

AincA - B005003790

Evacuator, Gas, In-line, w/Adjustable Pop-Off, 15mmM x 15mmF x 1/4" Suction w/Neg Relief, Delrin
ANESTHESIA ASSOCIATES, INC.
00-379
In Commercial Distribution

  • B005003790 ()
00-379

  • Mechanical expiratory valve, reusable

AincA - B00500274MRI0

Manometer, Pressure, MRI Cond 3T, -40 to +80 cm H2O, w/ Adjust. APL Relief Valve (0-60 cmH2O), 1/4" Inlet
ANESTHESIA ASSOCIATES, INC.
00-274-MRI
In Commercial Distribution

  • B00500274MRI0 ()
00-274-MRI

  • Mechanical expiratory valve, reusable

AincA - B00500274MAX0

Manometer, Pressure, Max Hold, -40 to +80 cm H2O, w/ Adjust. APL Relief Valve (0-60 cmH2O), 1/4" Inlet
ANESTHESIA ASSOCIATES, INC.
00-274-MAX
In Commercial Distribution

  • B00500274MAX0 ()
00-274-MAX

  • Mechanical expiratory valve, reusable

AincA - B005002740

Manometer, Pressure, -40 to +80 cm H2O, w/ Adjustable True APL Relief Valve (0-60 cmH2O), 1/4" Inlet
ANESTHESIA ASSOCIATES, INC.
00-274
In Commercial Distribution

  • B005002740 ()
00-274

  • Mechanical expiratory valve, reusable

AincA - B00500273MRI0

Valve, Pressure Relief, 0-60 cmH2O Adjustable True APL Valve, MRI Cond 3T, 1/2"-20 Inlet, Brass
ANESTHESIA ASSOCIATES, INC.
00-273-MRI
In Commercial Distribution

  • B00500273MRI0 ()
00-273-MRI

  • Mechanical expiratory valve, reusable

AincA - B005002730

Valve, Pressure Relief, 0-60 cmH2O Adjustable True APL Valve, 1/2"-20 Inlet, Chrome Brass
ANESTHESIA ASSOCIATES, INC.
00-273
In Commercial Distribution

  • B005002730 ()
00-273

  • Mechanical expiratory valve, reusable

AincA - B00500251D0

Valve, In-line Relief "T", 0-60 cmH2O Adjustable True APL Valve, 15mmF x 15mmM, Lightweight Black Delrin
ANESTHESIA ASSOCIATES, INC.
00-251-D
In Commercial Distribution

  • B00500251D0 ()
00-251-D

  • Mechanical expiratory valve, reusable

AincA - B00500233P0

Adapter, Mask Elbow w/Adjustable Pop-Off Valve, 15mmM x 22mmM/15mmF, Aluminum
ANESTHESIA ASSOCIATES, INC.
00-233-P
In Commercial Distribution

  • B00500233P0 ()
00-233-P

  • Mechanical expiratory valve, reusable

AincA - B005002290

Adapter, Mask Elbow, CPAP w/Adj Pop-Off, 15mmM x 22mmM/15mmF x 1/4" O2 x 1/4" Sensor, Aluminum
ANESTHESIA ASSOCIATES, INC.
00-229
In Commercial Distribution

  • B005002290 ()
00-229

  • Mechanical expiratory valve, reusable

AincA - B005002230

Adapter, Mask Elbow, w/Adjustable Pop-Off Valve (Large), 22mmM x 22mmM/15mmF, Translucent Acrylic
ANESTHESIA ASSOCIATES, INC.
00-223
In Commercial Distribution

  • B005002230 ()
00-223

  • Mechanical expiratory valve, reusable

AincA - B005004900

Adapter, Mask Elbow, CPAP w/Adj Pop-Off, 15mmM x 22mmM/15mmF x 1/4" O2 Inlet, Chrome Brass
ANESTHESIA ASSOCIATES, INC.
00-490
In Commercial Distribution

  • B005004900 ()
00-490

  • Mechanical expiratory valve, reusable

AincA - B005004880

Adapter, Mask Elbow, CPAP w/Adj Pop-Off, 15mmM x 22mmM/15mmF x 1/4"O2 x 1/4"Sensor, Chrome Brass
ANESTHESIA ASSOCIATES, INC.
00-488
In Commercial Distribution

  • B005004880 ()
00-488

  • Mechanical expiratory valve, reusable

AincA - B00500452P0

Adapter, Mask Elbow w/Adjustable Pop-Off Valve, 15mmM x 22mmM/15mmF, Conductive Neoprene
ANESTHESIA ASSOCIATES, INC.
00-452-P
In Commercial Distribution

  • B00500452P0 ()
00-452-P

  • Mechanical expiratory valve, reusable
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