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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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Aurora Xi Plasmapheresis System - 04086000101967

Aurora Xi Plasmapheresis System Software Version 1.2
Fresenius Kabi AG
1.2
In Commercial Distribution

  • 04086000101967 ()


  • Apheresis system

Vmax - 10846446027600

SOFTWARE KIT,VMAX ENCORE VERSION 20-5B CD
Carefusion Corporation
63654
Not in Commercial Distribution

  • 10846446027600 ()
63654

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult

Abbott - 00093815708452

Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
In Commercial Distribution

  • 30093815708453 ()
  • 00093815708452 ()
  • 00093815000839 ()
70845

  • Electrical-only medical device connection cable, reusable

Abbott - 00093815000839

Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
Not in Commercial Distribution

  • 30093815000830 ()
  • 00093815000839 ()
  • 57599-0845-1 ()
70845

  • Electrical-only medical device connection cable, reusable

Welch Allyn, Inc. - 00817655021058

Resting ECG connectivity gateway software v.5.0.0
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655021058 ()
11027-024-50

  • Electrocardiograph, professional, multichannel

CentriMag™ - 07640135140566

USB Stick containing Mag Log Converter Software
Thoratec Switzerland GmbH
201-52213
In Commercial Distribution

  • 07640135140566 ()
201-52213

  • Circulatory assist system application software

GoCheck Kids - B430GCKNOK4630

GoCheck Kids Native Software Application for Nokia.
Gobiquity, Inc.
Nokia 4.6.3
In Commercial Distribution

GCKNOK463

  • External ocular measurement camera

Zvu® - 00816734023426

Zvu® Functional GI Software Revision 3.4.0
DIVERSATEK HEALTHCARE, INC.
ZVU-3 Revision 3.4.0
In Commercial Distribution

  • 00816734023426 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system

L300 Go Clinician Programmer Software - 00815962020061

Clinician Programmer Software for L300 Go system
BIONESS INC.
LG4-SW01
In Commercial Distribution

  • 00815962020061 ()


  • Gait-enhancement electrical stimulation system, external

Esteem® Commander™ - 00812282020504

Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system

Esteem® Commander™ - 00812282020481

Esteem® Commander™ Software Version 2.2
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020481 ()
003873-010

  • Fully-implantable middle ear implant system

Esteem® Intraoperative System Analyzer - 00812282020429

Intraoperative System Analyzer (ISA), Software Version 9.0
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020429 ()
004652-005

  • Fully-implantable middle ear implant system

Esteem® Intraoperative System Analyzer - 00812282020160

Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system

Lumax™ TS Pro Advanced - 60888937013391

Lumax™ TS Pro Advanced • Software Kit
Coopersurgical, Inc.
23486
In Commercial Distribution

  • 60888937013391 ()


  • Urodynamic measurement system

Scopis ENT - 07613327413199

Scopis ENT Software with Target Guided Surgery
Stryker Leibinger GmbH & Co. KG
8000-020-002
In Commercial Distribution

  • 07613327413199 ()
8000-020-002

  • Stereotactic system application software

H200 Wireless - 00810188050601

Clinician Programmer Software for H200 Wireless System
Bioness Medical, Inc.
H2W-SW01
In Commercial Distribution



  • Hand orthosis

L300 Go System - 00810188050595

Clinician Programmer Software for L300 Go System
Bioness Medical, Inc.
LG4-SW01
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741231186

Site~Rite 9 Ultrasound Software v.1.2.0
Bard Access Systems, Inc.
SR9v1.2.0
In Commercial Distribution

  • 00801741231186 ()
SR9v1.2.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

Site Rite 8 Ultrasound System - 00801741219405

Site Rite 8 Ultrasound System Application Software
Bard Access Systems, Inc.
SR8v2.4.0
In Commercial Distribution

  • 00801741219405 ()
SR8v2.4.0

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741161094

Site~Rite 8 Ultrasound System Host Software
Bard Access Systems, Inc.
SR8 USv2.1.0
In Commercial Distribution

  • 00801741161094 ()
SR8 USv2.1.0

  • General-purpose ultrasound imaging system

AMICUS Separator Legacy Software - 00810020441208

Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.51.0
In Commercial Distribution

  • 00810020441208 ()


  • Apheresis system

AMICUS Separator Legacy Software - 00810020440591

Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.13.0
In Commercial Distribution

  • 00810020440591 ()


  • Apheresis system

PillCam - 07290110360191

PillCam™ Software v9.0 for WS, USA
Given Imaging, Inc.
FGS-0637
In Commercial Distribution

  • 07290110360191 ()


  • Video capsule endoscopy system application software

Cytomics FC500 - 15099590572822

Cytomics FC 500 MPL with MXP Software
Beckman Coulter, Inc.
UPS (MPL)
In Commercial Distribution

  • 15099590572822 ()
626554

  • Flow cytometry analyser IVD, semi-automated

Navios EX - 15099590683276

NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution

  • 15099590683276 ()
B91240

  • Laboratory instrument/analyser application software IVD

ECG - 15099169413334

BT12 ECG AHA WITH SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution

  • 05099169413337 ()
  • 15099169413334 ()


  • Electrocardiograph, professional, multichannel

ECG - 15099169413303

BT-12 ECG IEC with SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution

  • 05099169413306 ()
  • 15099169413303 ()


  • Electrocardiograph, professional, multichannel

ViroSeq - 00884999039278

ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor
ABBOTT MOLECULAR INC.
4J94-23
In Commercial Distribution

  • 00884999039278 ()
4J94-23

  • Laboratory instrument/analyser application software IVD

TRITON - 00859506006173

TRITON AI
STRYKER CORPORATION
GAUS-6
In Commercial Distribution

  • 00859506006173 ()
GAUS-6

  • Blood loss estimation application software

Triton Sponge System- NUI Sensor Bracket - 00859506006098

NUI Sensor Bracket for Tryten Cart
STRYKER CORPORATION
PN 11028
In Commercial Distribution

  • 00859506006098 ()


  • Blood loss estimation application software

TRITON - 00859506006067

TRITON SPONGE
STRYKER CORPORATION
GAUS-3
In Commercial Distribution

  • 00859506006067 ()
GAUS-3

  • Blood loss estimation application software

Triton System (Sponge) - 00859506006050

No Description
STRYKER CORPORATION
GAUS-01
Not in Commercial Distribution

  • 00859506006050 ()


  • Blood loss estimation application software

TRITON - 00859506006029

TRITON CANISTER
STRYKER CORPORATION
GAUS-2
In Commercial Distribution

  • 00859506006029 ()
GAUS-2

  • Blood loss estimation application software

Propeller - 00859105006345

The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed pMDI usage for the Symbicort device. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the pMDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their pMDI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. When used with a prescribed pMDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing pMDI technique. The Propeller System is intended to be used in populations from Child (>2 years) to Adult. The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of pMDI medication(s) by a participant. The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an pMDI dose counter, nor is it intended to indicate the quantity of medication remaining in an pMDI.
RECIPROCAL LABS CORPORATION
Sensor Model 2018-S
In Commercial Distribution

  • 00859105006345 ()


  • Inhaler dose sensor

Propeller - 00859105006338

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML
In Commercial Distribution

  • 00859105006338 ()


  • Inhaler dose sensor

Propeller - 00859105006321

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2016MS
In Commercial Distribution

  • 00859105006321 ()


  • Inhaler dose sensor

Propeller - 00859105006314

The convenience kit contains the following products: 2 x Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2016ML
In Commercial Distribution

  • 00859105006314 ()


  • Inhaler dose sensor

Propeller - 00859105006307

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068) Qualcomm 2Net Hub (GTIN-14: 00857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2015E
In Commercial Distribution

  • 00859105006307 ()


  • Inhaler dose sensor

Propeller - 00859105006291

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2014D
In Commercial Distribution

  • 00859105006291 ()


  • Inhaler dose sensor

Propeller - 00859105006284

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2014R
In Commercial Distribution

  • 00859105006284 ()


  • Inhaler dose sensor
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