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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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MediPines Gas Exchange Monitor Starter Kit - 00860001261530

Breathing Circuit and Nose Clip, Single Use, 10 pieces each
MEDIPINES CORPORATION
MPSK10
In Commercial Distribution

  • 00860001261530 ()
  • 00860001261554 ()
MPSK10

  • Nose clip, single-use
  • Breathing mouthpiece, single-use

MediPines Single Patient Use Breathing Circuit - 00860001261516

Breathing Circuit Kit, Single Patient Use, 10
MEDIPINES CORPORATION
AGM316
In Commercial Distribution

  • 00860001261516 ()
  • 00860001261523 ()
  • 00860001261547 ()
  • 00860001261561 ()
AGM316-10, AGM316-50, AGM316-100

  • Breathing mouthpiece, single-use

HEMOSPHERE - 00690103199338

DPT OUT CABLE
Edwards Lifesciences LLC
HEMDPT1000
In Commercial Distribution

  • 00690103199338 ()

  • Length: 15.2 Inch
HEMDPT1000

  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729948377

ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14510
In Commercial Distribution

  • 08714729948377 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948360

ECG OUT Box
BOSTON SCIENTIFIC CORPORATION
M004RH14010
In Commercial Distribution

  • 08714729948360 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948322

Breakout Box
BOSTON SCIENTIFIC CORPORATION
M004RH11020
In Commercial Distribution

  • 08714729948322 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729938668

Stimulator Jumper Cable
BOSTON SCIENTIFIC CORPORATION
M004RAMMTIPS220
In Commercial Distribution

  • 08714729938668 ()
M004RAMMTIPS220

  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729938651

Patch Cable
BOSTON SCIENTIFIC CORPORATION
M004RALRCBL20
In Commercial Distribution

  • 08714729938651 ()


  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729938620

CardioLab™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9100ECG60
In Commercial Distribution

  • 08714729938620 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938613

CardioLab™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9100ECG30
In Commercial Distribution

  • 08714729938613 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938569

Clearsign™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9000ECG60
In Commercial Distribution

  • 08714729938569 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938552

Clearsign™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9000ECG30
In Commercial Distribution

  • 08714729938552 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938545

Localization Generator Cable
BOSTON SCIENTIFIC CORPORATION
M004RA71010
In Commercial Distribution

  • 08714729938545 ()
M004RA71010

  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729938538

ECG IN Cable (Limb and Chest)
BOSTON SCIENTIFIC CORPORATION
M004RA5110I0
In Commercial Distribution

  • 08714729938538 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938521

ECG IN Cable (Limb and Chest)
BOSTON SCIENTIFIC CORPORATION
M004RA5110A0
In Commercial Distribution

  • 08714729938521 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938514

ECG IN Cable (Trunk)
BOSTON SCIENTIFIC CORPORATION
M004RA5010I0
In Commercial Distribution

  • 08714729938514 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938507

ECG IN Cable (Trunk)
BOSTON SCIENTIFIC CORPORATION
M004RA5010A0
In Commercial Distribution

  • 08714729938507 ()


  • Electrocardiographic lead set, reusable

Fenwal DXT Relay - 00811137013050

Fenwal DXT Relay is a Microsoft Windows-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and computer systems. The data may also be stored in and accessed from Fenwal DXT Relay’s database
FENWAL, INC.
2.2
In Commercial Distribution

  • 00811137013050 ()
5S9804

  • Blood bank information system application software
  • Medical equipment clinical data interfacing software

EV1000 - 00690103190151

EV1000 VOLUMEVIEW CABLE
Edwards Lifesciences LLC
EVVVTC1
In Commercial Distribution

  • 00690103190151 ()

  • Length: 93 Inch
EVVVTC1

  • Electrical-only medical device connection cable, reusable
  • Patient positioning sensor

Persona Medical - 00851362008049

Voicepro NOAH is fitting software with a NOAH Database used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss. The Noah software system is designed specifically for the hearing care industry, providing hearing care professionals with a unified system for performing client-related tasks.
Persona Medical
Voicepro Fitting Software NOAH
In Commercial Distribution

  • 00851362008049 ()


  • Hearing aid wireless-fitting computer-aided set
  • Air-conduction hearing aid, behind-the-ear

Persona Medical - 00851362008032

Voicepro is fitting software used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss.
Persona Medical
Voicepro Fitting Software
In Commercial Distribution

  • 00851362008032 ()


  • Hearing aid wireless-fitting computer-aided set
  • Air-conduction hearing aid, behind-the-ear

SPECTRALIS - 04059237001034

No Description
Heidelberg Engineering GmbH
Software V.7.2-US with Heidelberg Eye Explorer
In Commercial Distribution

  • 04059237001034 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237001027

No Description
Heidelberg Engineering GmbH
Software V.7.2-US
In Commercial Distribution

  • 04059237001027 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000891

No Description
Heidelberg Engineering GmbH
S2002
In Commercial Distribution

  • 04059237000891 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000884

No Description
Heidelberg Engineering GmbH
S1002
In Commercial Distribution

  • 04059237000884 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000839

No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V7.0-US
In Commercial Distribution

  • 04059237000839 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000815

No Description
Heidelberg Engineering GmbH
Software V7.0-US
In Commercial Distribution

  • 04059237000815 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000792

No Description
Heidelberg Engineering GmbH
S2610 [SN>20000]
In Commercial Distribution

  • 04059237000792 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000723

No Description
Heidelberg Engineering GmbH
S3610 [SN>20000]
In Commercial Distribution

  • 04059237000723 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000716

No Description
Heidelberg Engineering GmbH
SP-PWS-2001A [>20000]
In Commercial Distribution

  • 04059237000716 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000594

No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.12_US
In Commercial Distribution

  • 04059237000594 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000570

No Description
Heidelberg Engineering GmbH
Software 6.12_US
In Commercial Distribution

  • 04059237000570 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system

SPECTRALIS - 04059237000549

No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.10-US
In Commercial Distribution

  • 04059237000549 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system

SPECTRALIS - 04059237000525

No Description
Heidelberg Engineering GmbH
Software V6.10-US
In Commercial Distribution

  • 04059237000525 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system

SPECTRALIS - 04059237000501

No Description
Heidelberg Engineering GmbH
SP-PWS-1001A
In Commercial Distribution

  • 04059237000501 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system

SPECTRALIS - 04059237000488

No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.14_US
In Commercial Distribution

  • 04059237000488 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system

SPECTRALIS - 04059237000464

No Description
Heidelberg Engineering GmbH
Software 6.13_US
In Commercial Distribution

  • 04059237000464 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system

SPECTRALIS - 04059237000358

No Description
Heidelberg Engineering GmbH
Product Famliy with HEYEX 2 SW V6.9b-US
In Commercial Distribution

  • 04059237000358 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000341

No Description
Heidelberg Engineering GmbH
Product Family SW V6.9.1-US
In Commercial Distribution

  • 04059237000341 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system

SPECTRALIS - 04059237000310

No Description
Heidelberg Engineering GmbH
Product Family SW V6.8a-US
In Commercial Distribution

  • 04059237000310 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
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