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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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Ambu® aScope™ 5 Uretero - 05707480161584

Flexible Ureteroscope, Reverse Deflection
Ambu A/S
605101000
In Commercial Distribution

  • 05707480161591 ()
  • 05707480161584 ()
  • 05707480161607 ()

  • Lumen/Inner Diameter: 1.2 Millimeter
  • Outer Diameter: 3 Millimeter
  • Length: 780 Millimeter
605101000

  • Flexible video ureterorenoscope, single-use

Ambu® aScope™ 5 Uretero - 05707480161553

Flexible Ureteroscope, Standard Deflection
Ambu A/S
604101000
In Commercial Distribution

  • 05707480161560 ()
  • 05707480161553 ()
  • 05707480161577 ()

  • Length: 780 Millimeter
  • Lumen/Inner Diameter: 1.2 Millimeter
  • Outer Diameter: 3 Millimeter
604101000

  • Flexible video ureterorenoscope, single-use

Ambu® SureSight® Connect - 05707480159383

Reusable Video Laryngoscope Adapter
Ambu A/S
390511000
In Commercial Distribution

  • 05707480159390 ()
  • 05707480159383 ()
390511000

  • Electrical-only medical device connection cable, reusable

Ambu® SureSight® Blade - 05707480159352

Video Laryngoscope Blade
Ambu A/S
390341000
In Commercial Distribution

  • 05707480159369 ()
  • 05707480159352 ()
  • 05707480159376 ()

  • MAC #4
390341000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159321

Video Laryngoscope Blade
Ambu A/S
390331000
In Commercial Distribution

  • 05707480159338 ()
  • 05707480159321 ()
  • 05707480159345 ()

  • MAC #3
390331000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159291

Video Laryngoscope Blade
Ambu A/S
390241000
In Commercial Distribution

  • 05707480159314 ()
  • 05707480159307 ()
  • 05707480159291 ()

  • HYPER #4
390241000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159260

Video Laryngoscope Blade
Ambu A/S
390531000
In Commercial Distribution

  • 05707480159277 ()
  • 05707480159260 ()
  • 05707480159284 ()

  • HYPER #3C
390531000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159239

Video Laryngoscope Blade
Ambu A/S
390231000
In Commercial Distribution

  • 05707480159246 ()
  • 05707480159239 ()
  • 05707480159253 ()

  • HYPER #3
390231000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159208

Video Laryngoscope Blade
Ambu A/S
390521000
In Commercial Distribution

  • 05707480159222 ()
  • 05707480159215 ()
  • 05707480159208 ()

  • HYPER #2C
390521000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159178

Video Laryngoscope Blade
Ambu A/S
390221000
In Commercial Distribution

  • 05707480159192 ()
  • 05707480159185 ()
  • 05707480159178 ()

  • HYPER #2
390221000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159147

Video Laryngoscope Blade
Ambu A/S
390211000
In Commercial Distribution

  • 05707480159154 ()
  • 05707480159147 ()
  • 05707480159161 ()

  • HYPER #1
390211000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159116

Video Laryngoscope Blade
Ambu A/S
390111000
In Commercial Distribution

  • 05707480159123 ()
  • 05707480159116 ()
  • 05707480159130 ()

  • MILLER #1
390111000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159086

Video Laryngoscope Blade
Ambu A/S
390101000
In Commercial Distribution

  • 05707480159109 ()
  • 05707480159093 ()
  • 05707480159086 ()

  • MILLER #0
390101000

  • Laryngoscope blade, single-use

Ambu® aScope™ 5 Broncho 2.7/1.2 - 05707480157280

Single-Use Flexible Endoscope
Ambu A/S
624001000US
In Commercial Distribution

  • 05707480157297 ()
  • 05707480157280 ()
  • 05707480157303 ()

  • Outer Diameter: 2.7 Millimeter
  • Outer Diameter: 4.2 Millimeter
  • Lumen/Inner Diameter: 1.2 Millimeter
  • Length: 600 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
624001000US

  • Flexible video bronchoscope, single-use

Ambu® aScope™ 5 Broncho 4.2/2.2 - 05707480157259

Single-Use Flexible Endoscope
Ambu A/S
620001000US
In Commercial Distribution

  • 05707480157266 ()
  • 05707480157259 ()
  • 05707480157273 ()

  • Outer Diameter: 4.2 Millimeter
  • Length: 600 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
620001000US

  • Flexible video bronchoscope, single-use

Ambu® aScope™ Duodeno 2 - 05707480157167

Duodenoscope
Ambu A/S
486101000
In Commercial Distribution

  • 05707480157167 ()

  • Lumen/Inner Diameter: 4.2 Millimeter
  • Outer Diameter: 13.7 Millimeter
  • Length: 1240 Millimeter
486101000

  • Flexible video duodenoscope, single-use

Ambu® aScope™ Duodeno 2 - 05707480157143

Duodenoscope
Ambu A/S
486104000
In Commercial Distribution

  • 05707480157136 ()
  • 05707480157143 ()

  • Outer Diameter: 13.7 Millimeter
  • Lumen/Inner Diameter: 4.2 Millimeter
  • Length: 1240 Millimeter
486104000

  • Flexible video duodenoscope, single-use

Ambu aView™ 2 Advance - 05707480156757

Ambu aView 2 Advance (gen2) US CIB V2
Ambu A/S
405011000US2
In Commercial Distribution

  • 05707480156757 ()
405011000US2

  • Endoscopic video image display unit

Ambu aView™ 2 Advance - 05707480156689

Ambu aView 2 Advance (gen2) US CIB V1
Ambu A/S
405011000US1
In Commercial Distribution

  • 05707480156689 ()
405011000US1

  • Endoscopic video image display unit

aScope™ 5 Broncho 4.2/2.2 Sampler Set - 05707480156481

Flexible Endoscope and Specimen Sampling System
Ambu A/S
620002000US
In Commercial Distribution

  • 05707480156504 ()
  • 05707480156498 ()
  • 05707480156481 ()

  • Length: 600 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
  • Outer Diameter: 4.2 Millimeter
620002000US

  • Flexible video bronchoscope, single-use

Ambu® aBox™ 2 - 05707480156290

Ambu aBox 2 US2
Ambu A/S
505001000US2
In Commercial Distribution

  • 05707480156290 ()
505001000US2

  • Endoscopic video image display unit

aBox™ 2 - 05707480156207

Ambu aBox 2 US1
Ambu A/S
505001000US1
In Commercial Distribution

  • 05707480156207 ()
505001000US1

  • Endoscopic video image display unit

aScope™ 4 Cysto - 05707480146345

aScope 4 Cysto - Standard Deflection (20 pcs)
Ambu A/S
601005000
In Commercial Distribution

  • 05707480146338 ()
  • 05707480146345 ()
  • 05707480146321 ()

  • Outer Diameter: 6 Millimeter
  • Length: 390 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
601005000

  • Flexible video cystoscope, single-use

aScope™ 4 Cysto - 05707480146314

aScope 4 Cysto - Reverse Deflection (20 pcs)
Ambu A/S
600005000
In Commercial Distribution

  • 05707480146291 ()
  • 05707480146307 ()
  • 05707480146314 ()

  • Length: 390 Millimeter
  • Outer Diameter: 6 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
600005000

  • Flexible video cystoscope, single-use

aScope™ 4 RhinoLaryngo Slim - 05707480146284

aScope 4 RhinoLaryngo Slim (20 pcs)
Ambu A/S
510005000
In Commercial Distribution

  • 05707480146277 ()
  • 05707480146284 ()
  • 05707480146260 ()

  • Length: 300 Millimeter
  • Outer Diameter: 3 Millimeter
510005000

  • Flexible video otorhinolaryngoscope, single-use

aScope™ 4 Broncho Large Sampler Set 5.8/2.8 - 05707480146017

aScope 4 Broncho Large Sampler Set
Ambu A/S
478501000
In Commercial Distribution

  • 05707480146000 ()
  • 05707480146017 ()
  • 05707480145997 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Outer Diameter: 5.8 Millimeter
  • Length: 600 Millimeter
478501000

  • Flexible video bronchoscope, single-use

aScope™ 4 Broncho Regular Sampler Set 5.0/2.2 - 05707480145980

aScope 4 Broncho Regular Sampler Set
Ambu A/S
477501000
In Commercial Distribution

  • 05707480145966 ()
  • 05707480145973 ()
  • 05707480145980 ()

  • Lumen/Inner Diameter: 2.2 Millimeter
  • Outer Diameter: 5 Millimeter
  • Length: 600 Millimeter
477501000

  • Flexible video bronchoscope, single-use

aScope™ 4 Broncho Slim 3.8/1.2 - 05707480135479

Flexible Endoscope
Ambu A/S
476001000
In Commercial Distribution

  • 05707480135486 ()
  • 05707480135479 ()
  • 05707480135493 ()

  • Length: 600 Millimeter
  • Lumen/Inner Diameter: 1.2 Millimeter
  • Outer Diameter: 3.8 Millimeter
476001000

  • Flexible video bronchoscope, single-use

aScope™ 4 RhinoLaryngo Slim - 05707480140664

Ambu aScope 4 RhinoLaryngo Slim Single-use, flexible Rhinolaryngoscope Sterile from package. Insertion cord diameter 3.0 mm, lenght of 300 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box
Ambu A/S
510001000
In Commercial Distribution

  • 05707480140640 ()
  • 05707480140657 ()
  • 05707480140664 ()

  • Outer Diameter: 3 Millimeter
  • Length: 300 Millimeter
510001000

  • Flexible video otorhinolaryngoscope, single-use

aScope™ 4 Cysto - 05707480140589

aScope 4 Cysto - Standard Deflection
Ambu A/S
601001000
In Commercial Distribution

  • 05707480140602 ()
  • 05707480140596 ()
  • 05707480140589 ()

  • Outer Diameter: 6 Millimeter
  • Length: 390 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
601001000

  • Flexible video cystoscope, single-use

aScope™ 4 Cysto - 05707480140558

aScope 4 Cysto - Reverse Deflection
Ambu A/S
600001000
In Commercial Distribution

  • 05707480140565 ()
  • 05707480140558 ()
  • 05707480140572 ()

  • Length: 390 Millimeter
  • Outer Diameter: 6 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
600001000

  • Flexible video cystoscope, single-use

aScope™ 4 RhinoLaryngo Intervention - 05707480136971

Ambu aScope 4 RhinoLaryngo Intervention Single-use, flexible Rhinolaryngoscope Sterile from package. 2.2 mm working channel, outer diameter 5.0 mm, lenght of 350 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box
Ambu A/S
512001000
In Commercial Distribution

  • 05707480136988 ()
  • 05707480136971 ()
  • 05707480136964 ()

  • Lumen/Inner Diameter: 2 Millimeter
  • Outer Diameter: 5 Millimeter
  • Length: 350 Millimeter
512001000

  • Flexible video otorhinolaryngoscope, single-use

aScope™ 4 Broncho Large 5.8/2.8 - 05707480135530

Flexible Endoscope
Ambu A/S
478001000
In Commercial Distribution

  • 05707480135547 ()
  • 05707480135530 ()
  • 05707480135554 ()

  • Length: 600 Millimeter
  • Outer Diameter: 5.8 Millimeter
  • Lumen/Inner Diameter: 2.8 Millimeter
478001000

  • Flexible video bronchoscope, single-use

aScope™ 4 Broncho Regular 5.0/2.2 - 05707480135509

Flexible Endoscope
Ambu A/S
477001000
In Commercial Distribution

  • 05707480135523 ()
  • 05707480135516 ()
  • 05707480135509 ()

  • Outer Diameter: 5 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
  • Length: 600 Millimeter
477001000

  • Flexible video bronchoscope, single-use

X-Series - 00851113007727

X24 Stat Device kit - Dongle
ADVANCED BRAIN MONITORING, INC.
XS24-1002
In Commercial Distribution

  • 00851113007628 ()
  • 00851113007727 ()


  • Electroencephalograph

X-Series - 00851113007710

X24 Stat Device Kit - ESU
ADVANCED BRAIN MONITORING, INC.
XS24-1001
In Commercial Distribution

  • 00851113007628 ()
  • 00851113007710 ()


  • Electroencephalograph

X-Series - 00851113007703

X10 Stat Device Kit
ADVANCED BRAIN MONITORING, INC.
XS10-1001, XS10-1003
In Commercial Distribution

  • 00851113007611 ()
  • 00851113007703 ()


  • Electroencephalograph

X-Series - 00851113007536

X24 Stat Device kit - Dongle
ADVANCED BRAIN MONITORING, INC.
XS30-1001, XS30-1003
In Commercial Distribution

  • 00851113007345 ()
  • 00851113007536 ()


  • Electroencephalograph

Sleep Profiler - 00851113007208

Sleep Profiler Device Kit
ADVANCED BRAIN MONITORING, INC.
SP40-1001, SP29-1003
In Commercial Distribution

  • 00851113007154 ()
  • 00851113007208 ()


  • Electroencephalograph

Sleep Profiler PSG2 - 00851113007987

Sleep Profiler PSG2 LE Device Kit - Piezo
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE, SP29-1009.LE
In Commercial Distribution

  • 00851113007949 ()
  • 00851113007987 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler PSG2 - 00851113007970

Sleep Profiler PSG2 LE Device kit - ezRIP
ADVANCED BRAIN MONITORING, INC.
SP29-1001.LE, SP29-1008.LE
In Commercial Distribution

  • 00851113007949 ()
  • 00851113007970 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler PSG2 - 00851113007963

Sleep Profiler PSG2 LE Device Kit No Belts (PM3)
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE, SP29-1007.LE
In Commercial Distribution

  • 00851113007949 ()
  • 00851113007963 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler - 00851113007956

Sleep Profiler LE Device Kit
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE, SP29-1003.LE
In Commercial Distribution

  • 00851113007949 ()
  • 00851113007956 ()


  • Electroencephalograph

X-Series - 00851113007925

X24 Stat Device Kit - ESU (PAN 1026A)
ADVANCED BRAIN MONITORING, INC.
XS30-1001
In Commercial Distribution

  • 00851113007925 ()
  • 00851113007345 ()


  • Electroencephalograph

X-Series - 00851113007857

X10 Stat Device Kit (PAN 1026)
ADVANCED BRAIN MONITORING, INC.
XS30-1004, XS30-1005
In Commercial Distribution

  • 00851113007857 ()


  • Electroencephalograph

X-Series - 00851113007840

X24 Stat Device kit - Dongle (PAN 1026)
ADVANCED BRAIN MONITORING, INC.
XS30-1002, XS30-1003
In Commercial Distribution

  • 00851113007840 ()


  • Electroencephalograph

X-Series - 00851113007826

X10 Stat Device Kit
ADVANCED BRAIN MONITORING, INC.
XS30-1004, XS30-1005
In Commercial Distribution

  • 00851113007345 ()
  • 00851113007826 ()


  • Electroencephalograph

Sleep Profiler - 00851113007741

Sleep Profiler System Kit - TRL
ADVANCED BRAIN MONITORING, INC.
SP40-1003
In Commercial Distribution

  • 00851113007741 ()


  • Electroencephalograph

X-Series - 00851113007734

X24 Stat Device Kit - TRL
ADVANCED BRAIN MONITORING, INC.
XS24-1003
In Commercial Distribution

  • 00851113007628 ()
  • 00851113007734 ()


  • Electroencephalograph

X-Series - 00851113007529

X24 Stat Device Kit - ESU
ADVANCED BRAIN MONITORING, INC.
XS30-1001
In Commercial Distribution

  • 00851113007345 ()
  • 00851113007529 ()


  • Electroencephalograph
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