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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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PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020080090
In Commercial Distribution

  • 00821684050354 ()

  • Outer Diameter: 2 Millimeter
  • Length: 80 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic
PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020060090
In Commercial Distribution

  • 00821684050347 ()

  • Length: 60 Millimeter
  • Outer Diameter: 2 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic
PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020040090
In Commercial Distribution

  • 00821684050330 ()

  • Length: 40 Millimeter
  • Outer Diameter: 2 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic
PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020020090
In Commercial Distribution

  • 00821684050323 ()

  • Length: 20 Millimeter
  • Outer Diameter: 2 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic
STR EXIT SITE SET EXCHANGE KIT
Cardinal Health 200, LLC
SBA33ESCAG
In Commercial Distribution

  • 50885425982309 ()
  • 10885425982301 ()
SBA33ESCAG

  • General surgical procedure kit, medicated
Hemoglobin Variants System Cation Exchange Mini-Columns
BIO-RAD LABORATORIES, INC.
250-0014
In Commercial Distribution

  • 00847817007163 ()
2500014

  • Inherited haemoglobinopathy IVD, reagent
Hemoglobin Variants System Cation Exchange Mini-Columns
BIO-RAD LABORATORIES, INC.
250-0014
In Commercial Distribution

  • 00847817006791 ()
2500014

  • Inherited haemoglobinopathy IVD, reagent
1000 Heat and Moisture Exchange Filter
Avanos Medical, Inc.
93821
In Commercial Distribution

  • 10609038938216 ()
  • 00609038938219 ()
157

  • Heat/moisture exchanger, single-use
PLPL Exchange Select DPS Early Result
SPD SWISS PRECISION DIAGNOSTICS GMBH
PLPL
In Commercial Distribution

  • 00614299402676 ()
  • 10614299402673 ()
  • 00633472000126 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Heat And Moisture Exchange Filters (HMEF)
FOREMOUNT ENTERPRISE CO., LTD.
400-1046/25
In Commercial Distribution

  • 04719871892251 ()


  • Heat/moisture exchanger/microbial medical gas filter
AxiaLIF Plus Exchange System Fixation Wire
QUANDARY MEDICAL LLC
TR1-2212
In Commercial Distribution

  • 00815361020297 ()


  • Orthopaedic bone wire
11mm Trocar Screw Shaft for Exchange
Surgical Direct, Inc.
SD10179
In Commercial Distribution

  • B382SD101790 ()

  • Outer Diameter: 11 Millimeter
SD10179

  • Endoscope sheath, reusable
Universa Loop Drainage Catheter Exchange Set
COOK INCORPORATED
G55808
In Commercial Distribution

  • 00827002558083 ()
ULC-12-30

  • Nephrostomy catheter
Universa Loop Drainage Catheter Exchange Set
COOK INCORPORATED
G55807
In Commercial Distribution

  • 00827002558076 ()
ULC-10-30

  • Nephrostomy catheter
Universa Loop Drainage Catheter Exchange Set
COOK INCORPORATED
G55806
In Commercial Distribution

  • 00827002558069 ()
ULC-8-30

  • Nephrostomy catheter
Universa Loop Drainage Catheter Exchange Set
COOK INCORPORATED
G55805
In Commercial Distribution

  • 00827002558052 ()
ULC-6-15

  • Nephrostomy catheter
Xper FC2010 Rev D Russia Exchange
Philips Ds North America LLC
Xper FC2010 Rev D Russia Exchange
Not in Commercial Distribution

  • 00884838091498 ()
453564674581

  • General-purpose multi-parameter bedside monitor
PROBP 3400 STANDARD W SUREBP EXCHANGE
WELCH ALLYN, INC.
901055
In Commercial Distribution

  • 00732094009125 ()
34XF-EX

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Xper FC2010 REV E Russian Exchange
Philips Ds North America LLC
Xper FC2010 REV E Russian Exchange
In Commercial Distribution

  • 00884838095069 ()
453564845881

  • General-purpose multi-parameter bedside monitor
HR300 Mini Holter Recorder Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020290 ()
404955

  • Electrocardiographic ambulatory recorder
CUSTOM PACK CB10M30R OXY EXCHANGE P
MEDTRONIC, INC.
CB10M30R
In Commercial Distribution

  • 00763000123741 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
Merit Medical Systems, Inc.
00884450236208
In Commercial Distribution

  • 10884450236205 ()
  • 00884450236208 ()
  • 20884450236202 ()

  • Tip Shape-Straight Tip
  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Configuration-Standard Exchange; Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
  • Length-260 cm (102"); Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
LWSTDS35260EX/D

  • Peripheral vascular guidewire, manual
No Description
Merit Medical Systems, Inc.
00884450022771
In Commercial Distribution

  • 20884450022775 ()
  • 10884450022778 ()
  • 00884450022771 ()

  • Tip Shape-Straight Tip
  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Length-260 cm (102"); Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
  • Configuration-Standard Exchange; Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
IQ38F260S/B

  • Cardiac/peripheral vascular guidewire, single-use
No Description
Merit Medical Systems, Inc.
00884450033371
In Commercial Distribution

  • 10884450033378 ()
  • 00884450033371 ()
  • 20884450033375 ()

  • Length-260 cm (102")
  • Configuration-Stiff Exchange
  • Tip Shape-Straight Tip
  • Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Stiff Exchange; Tip Shape-Straight Tip
  • Configuration-Stiff Exchange; Length-260 cm (102"); Configuration-Stiff Exchange; Tip Shape-Straight Tip
LWSTFS35260EX/D

  • Peripheral vascular guidewire, manual
For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange tubing set
OXBRIDGE AFN DISPOSABLES - DRILLS / PIN & EXCHANGE TUBE
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333013
In Commercial Distribution

  • 05055662944761 ()
OS333013

  • Joint prosthesis implantation kit, single-use
OXBRIDGE AFN DISPOSABLES - DRILLS / PIN & EXCHANGE TUBE
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333013
In Commercial Distribution

  • 05055662962420 ()
OS333013

  • Joint prosthesis implantation kit, single-use
Alice PDx Unit Only, Warranty Exchange, International
Respironics, Inc.
Alice PDx Unit Only, Warranty Exchange, INTL
In Commercial Distribution

  • 00606959020689 ()
1057624

  • Polysomnograph
Alice PDx Unit Only, Warranty Exchange, JP
Respironics, Inc.
Alice PDx Unit Only, Warranty Exchange, JP
Not in Commercial Distribution

  • 00606959038981 ()
1057626

  • Polysomnograph
CABLE CAMERA W/TOOL F/HEAD EXCHANGE
JEDMED INSTRUMENT COMPANY
70-6521
In Commercial Distribution

  • M6337065210 ()
70-6521

  • Throat microphone
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