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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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GlidePath - 00801741187452

GlidePath 13F Long-Term Hemodialysis Catheter Exchange Kit, 19 cm
Bard Peripheral Vascular, Inc.
5347190
In Commercial Distribution

  • 10801741187459 ()
  • 00801741187452 ()

  • Catheter Gauge: 13 French
  • Length: 19 Centimeter
5347190

  • Double-lumen haemodialysis catheter, implantable

GlidePath - 00801741187445

GlidePath 13F Long-Term Hemodialysis Catheter Exchange Kit, 15 cm
Bard Peripheral Vascular, Inc.
5347150
In Commercial Distribution

  • 10801741187442 ()
  • 00801741187445 ()

  • Catheter Gauge: 13 French
  • Length: 15 Centimeter
5347150

  • Double-lumen haemodialysis catheter, implantable

Vis-Rx Prime - 00859910007148

1.8F Rapid exchange micro-imaging high-frequency OCT catheter kit - US
GENTUITY LLC
G31
In Commercial Distribution

  • 00859910007148 ()

  • Catheter Gauge: 1.8 French
G31-01

  • Coronary optical coherence tomography system catheter

InQwire® - 00884450028131

No Description
Merit Medical Systems, Inc.
00884450028131
In Commercial Distribution

  • 20884450028135 ()
  • 10884450028138 ()
  • 00884450028131 ()

  • Length-260 cm (102")
  • Configuration-Bentson (23 cm) Exchange
  • Tip Shape-Straight Tip
  • Configuration-Bentson (23 cm) Exchange; Length-260 cm (102"); Configuration-Bentson (23 cm) Exchange; Tip Shape-Straight Tip
  • Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Bentson (23 cm) Exchange; Tip Shape-Straight Tip
IQ35F260B/B

  • Cardiac/peripheral vascular guidewire, single-use

Merit Laureate® - 00884450033425

No Description
Merit Medical Systems, Inc.
00884450033425
In Commercial Distribution

  • 10884450033422 ()
  • 00884450033425 ()
  • 20884450033429 ()

  • Tip Shape-Angled Tip
  • Length-260 cm (102")
  • Configuration-Standard Exchange
LWSTDA25260EX/D

  • Peripheral vascular guidewire, manual

Merit H2O™ - 00884450056226

No Description
Merit Medical Systems, Inc.
00884450056226
In Commercial Distribution

  • 10884450056223 ()
  • 00884450056226 ()

  • Configuration-Stiff Exchange
  • Tip Shape-Angled Tip
  • Length-260 cm (102")
H2OSTFA35260EX/A

  • Peripheral vascular guidewire, manual

Merit H2O™ - 00884450056165

No Description
Merit Medical Systems, Inc.
00884450056165
In Commercial Distribution

  • 10884450056162 ()
  • 00884450056165 ()

  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Tip Shape-Angled Tip
H2OSTDA25260EX/A

  • Peripheral vascular guidewire, manual

Merit Laureate® - 00884450093979

No Description
Merit Medical Systems, Inc.
00884450093979
In Commercial Distribution

  • 10884450093976 ()
  • 00884450093979 ()
  • 20884450093973 ()

  • Length-260 cm (102")
  • Tip Shape-Angled Tip
  • Configuration-Standard Exchange
LWSTDA18260EX/D

  • Peripheral vascular guidewire, manual

Merit H2O™ - 00884450056943

No Description
Merit Medical Systems, Inc.
00884450056943
In Commercial Distribution

  • 10884450056940 ()
  • 00884450056943 ()

  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Tip Shape-Angled Tip
H2OSTDA18260EX/A

  • Peripheral vascular guidewire, manual

Merit H2O™ - 00884450056240

No Description
Merit Medical Systems, Inc.
00884450056240
In Commercial Distribution

  • 10884450056247 ()
  • 00884450056240 ()

  • Tip Shape-Straight Tip
  • Length-260 cm (102")
  • Configuration-Stiff Exchange
H2OSTFS35260EX/A

  • Peripheral vascular guidewire, manual

Merit H2O™ - 00884450056189

No Description
Merit Medical Systems, Inc.
00884450056189
In Commercial Distribution

  • 10884450056186 ()
  • 00884450056189 ()

  • Configuration-Standard Exchange
  • Tip Shape-Angled Tip
  • Length-260 cm (102")
H2OSTDA35260EX/A

  • Peripheral vascular guidewire, manual

Merit Laureate® - 00884450236475

No Description
Merit Medical Systems, Inc.
00884450236475
In Commercial Distribution

  • 10884450236472 ()
  • 00884450236475 ()
  • 20884450236479 ()

  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Tip Shape-Straight Tip
LWSTDS38260EX/D

  • Peripheral vascular guidewire, manual

Merit Laureate® - 00884450236246

No Description
Merit Medical Systems, Inc.
00884450236246
In Commercial Distribution

  • 20884450236240 ()
  • 10884450236243 ()
  • 00884450236246 ()

  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Tip Shape-Straight Tip
LWSTDS25260EX/D

  • Peripheral vascular guidewire, manual

Merit Laureate® - 00884450235744

No Description
Merit Medical Systems, Inc.
00884450235744
In Commercial Distribution

  • 10884450235741 ()
  • 00884450235744 ()
  • 20884450235748 ()

  • Configuration-Standard Exchange
  • Tip Shape-Straight Tip
  • Length-260 cm (102")
LWSTDS18260EX/D

  • Peripheral vascular guidewire, manual

Merit Laureate® - 00884450235447

No Description
Merit Medical Systems, Inc.
00884450235447
In Commercial Distribution

  • 10884450235444 ()
  • 00884450235447 ()
  • 20884450235441 ()

  • Tip Shape-Angled Tip
  • Configuration-Standard Exchange
  • Length-260 cm (102")
LWSTDA38260EX/D

  • Peripheral vascular guidewire, manual

SplashWire™ - 00884450529850

No Description
Merit Medical Systems, Inc.
00884450529850
In Commercial Distribution

  • 10884450529857 ()
  • 00884450529850 ()
  • 20884450529854 ()

  • Length-260 cm (102")
  • Tip Shape-Straight Tip
  • Configuration-Standard Exchange
MSWSTDS38260EX

  • Peripheral vascular guidewire, manual

SplashWire™ - 00884450529812

No Description
Merit Medical Systems, Inc.
00884450529812
In Commercial Distribution

  • 10884450529819 ()
  • 00884450529812 ()
  • 20884450529816 ()

  • Length-260 cm (102")
  • Tip Shape-Angled Tip
  • Configuration-Standard Exchange
MSWSTDA38260EX

  • Peripheral vascular guidewire, manual

SplashWire™ - 00884450529461

No Description
Merit Medical Systems, Inc.
00884450529461
In Commercial Distribution

  • 10884450529468 ()
  • 00884450529461 ()
  • 20884450529465 ()

  • Configuration-Standard Exchange
  • Tip Shape-Angled Tip
  • Length-260 cm (102")
MSWSTDA25260EX

  • Peripheral vascular guidewire, manual

InQwire® Amplatz - 00884450239803

No Description
Merit Medical Systems, Inc.
00884450239803
In Commercial Distribution

  • 10884450239800 ()
  • 00884450239803 ()
  • 20884450239807 ()

  • Tip Shape-Straight Short (1.0 cm) Tip
  • Configuration-Amplatz Exchange
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange; Tip Shape-Straight Short (1.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102")
  • Length-260 cm (102"); Tip Shape-Straight Short (1.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102")
IQA509

  • Cardiac/peripheral vascular guidewire, single-use

InQwire® Amplatz - 00884450239773

No Description
Merit Medical Systems, Inc.
00884450239773
In Commercial Distribution

  • 10884450239770 ()
  • 00884450239773 ()
  • 20884450239777 ()

  • Tip Shape-Straight Short (1.0 cm) Tip
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange
  • Configuration-Amplatz Exchange; Tip Shape-Straight Short (1.0 cm) Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
  • Length-260 cm (102"); Tip Shape-Straight Short (1.0 cm) Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
IQA510

  • Cardiac/peripheral vascular guidewire, single-use

Bio30+ Physio W/O A/S HR - 05056336800284

Ion exchange chromatography analyzer sold with lithium high resolution column.
BIOCHROM LIMITED
80-6000-58
In Commercial Distribution

  • 05056336800284 ()


  • Amino acid analyser IVD

Bio30+ Physio W/O A/S HP - 05056336800253

Ion exchange chromatography analyzer sold with lithium high performance column.
BIOCHROM LIMITED
80-6000-55
In Commercial Distribution

  • 05056336800253 ()


  • Amino acid analyser IVD

Amplatz - 00827002203204

TFE Coated Curved Amplatz Ultra Stiff Wire Guide - Catheter Exchange
COOK INCORPORATED
G20320
In Commercial Distribution

  • 00827002203204 ()
THSCF-35-260-3-AUS2

  • Peripheral vascular guidewire, manual

PuriLens Plus Disinfecting System Exchange Kit - 00830002000056

Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.
LIFESTYLE CO INC, THE
MS0610/H
Not in Commercial Distribution

  • 00830002000056 ()


  • Contact lens agitation cleaning system, mechanical

Vis-Rx - 00859910007018

1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US
GENTUITY LLC
US Catheter Kit G30-01
In Commercial Distribution

  • 00859910007018 ()

  • Catheter Gauge: 1.8 French


  • Coronary optical coherence tomography system catheter

Ease Cushion - 00860000915304

Ease Cushion Pump
Ease Seating Systems
Pump
Not in Commercial Distribution

  • 00860000915304 ()


  • Alternating-pressure inflator

Guardian - 00860008160348

Guardian System V3 Controller
TURNCARE INC
GS-C
In Commercial Distribution

  • 00860008160348 ()


  • Alternating-pressure inflator

Ease Cushion - 00860002071237

No Description
Ease Seating Systems
Lite
Not in Commercial Distribution

  • 00860002071237 ()


  • Alternating-pressure inflator

Ease Cushion - 00860002071220

Ease Cushion Standard Pump
Ease Seating Systems
Standard Pump
Not in Commercial Distribution

  • 00860002071220 ()


  • Alternating-pressure inflator

Guardian - 00860001236453

Guardian System, 2.5 Controller
TURNCARE INC
GS-2.5-C
In Commercial Distribution

  • 00860001236453 ()
GS-2.5-C

  • Alternating-pressure inflator

PPS Air Blower - 00860010693179

No Description
PATIENT POSITIONING SYSTEMS, LLC
US Version
In Commercial Distribution

  • 00860010693179 ()


  • Alternating-pressure inflator

TurnCair - 00857268006882

TURNCAIR CONTROL UNIT, 220V, UK
JOERNS HEALTHCARE, LLC
TCLRUK-CU
In Commercial Distribution

  • 00857268006882 ()


  • Alternating-pressure inflator

ClimateCare DM Control Unit - 00857268006691

No Description
JOERNS HEALTHCARE, LLC
MCM-DM-CU
In Commercial Distribution

  • 00857268006691 ()
MCM-DM-CU

  • Alternating-pressure inflator

Turncair Control Unit - 00857268006684

No Description
JOERNS HEALTHCARE, LLC
TurnCair
In Commercial Distribution

  • 00857268006684 ()
TCLR-CU

  • Alternating-pressure inflator

DermaFloat LR Control Unit - 00857268006677

No Description
JOERNS HEALTHCARE, LLC
Dermafloat LR
In Commercial Distribution

  • 00857268006677 ()
DFLR-CU

  • Alternating-pressure inflator

ProMatt Plus - 00857268006660

No Description
JOERNS HEALTHCARE, LLC
PMP-CBC
In Commercial Distribution

  • 00857268006660 ()
PMP-CBC

  • Alternating-pressure inflator

PMP-ES2 - 00857268006653

No Description
JOERNS HEALTHCARE, LLC
PMP-ES2
In Commercial Distribution

  • 00857268006653 ()
PMP-ES2

  • Alternating-pressure inflator

Cair Turn RT - 00857268006646

No Description
JOERNS HEALTHCARE, LLC
Cair Turn RT Matt Controller
In Commercial Distribution

  • 00857268006646 ()
CTLR-CU

  • Alternating-pressure inflator

Cair LAL - 00857268006639

No Description
JOERNS HEALTHCARE, LLC
CRLAL-CU
In Commercial Distribution

  • 00857268006639 ()
CRLAL-CU

  • Alternating-pressure inflator

Cair APM - 00857268006622

No Description
JOERNS HEALTHCARE, LLC
Cair APM CU Matt Controller
In Commercial Distribution

  • 00857268006622 ()
CRAPM-CU

  • Alternating-pressure inflator
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