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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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Minuteful for Wound - 17290017272709

The Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
MNT WND.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272709 ()


  • Wound management image-analysis software

SPOT - 17290017272556

The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.G25
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272556 ()


  • Wound management image-analysis software

SPOT - 17290017272501

The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.GEN
In Commercial Distribution

  • 17290017272501 ()
  • 07290017272504 ()


  • Wound management image-analysis software

Brainlab Elements Image Fusion - 04056481140816

No Description
Brainlab AG
4.0
In Commercial Distribution

  • 04056481140816 ()


  • Radiological PACS software
  • Stereotactic system application software

Brainlab Elements Image Fusion Angio - 04056481138530

No Description
Brainlab AG
1.0
In Commercial Distribution

  • 04056481138530 ()


  • Radiological PACS software
  • Stereotactic system application software

Brainlab Elements Fibertracking - 04056481142186

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481142186 ()


  • Radiological PACS software
  • Stereotactic system application software

Clarius Ultrasound Scanner - 07540205000403

No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

Rapid - B761R610

Rapid System Update
Ischemaview, Inc.
6.1.0
In Commercial Distribution

  • B761R610 ()


  • Radiological PACS software

Rapid - B761R60

Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution

  • B761R60 ()


  • Radiological PACS 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

Propeller - 00859105006277

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)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016ML/SM2016MS
In Commercial Distribution

  • 00859105006277 ()


  • Inhaler dose sensor

Propeller - 00859105006260

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

  • 00859105006260 ()


  • Inhaler dose sensor

Propeller - 00859105006246

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

  • 00859105006246 ()


  • Inhaler dose sensor

Propeller - 00859105006239

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

  • 00859105006239 ()


  • Inhaler dose sensor

Propeller - 00859105006222

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

  • 00859105006222 ()


  • Inhaler dose sensor

Propeller - 00859105006215

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

  • 00859105006215 ()


  • Inhaler dose sensor

Propeller - 00859105006208

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

  • 00859105006208 ()


  • Inhaler dose sensor

Propeller - 00859105006192

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016MS/SM2015E
In Commercial Distribution

  • 00859105006192 ()


  • Inhaler dose sensor

Propeller - 00859105006185

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016MS/SM2014D
In Commercial Distribution

  • 00859105006185 ()


  • Inhaler dose sensor

Propeller - 00859105006178

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience kit - HUB/SM2016MS/SM2014R
In Commercial Distribution

  • 00859105006178 ()


  • Inhaler dose sensor

Propeller - 00859105006161

The convenience kit contains the following products: (2x) Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016MS/SM2016MS
In Commercial Distribution

  • 00859105006161 ()


  • Inhaler dose sensor

Propeller - 00859105006147

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016MS/SM2015E
In Commercial Distribution

  • 00859105006147 ()


  • Inhaler dose sensor

Propeller - 00859105006130

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016MS/SM2014D
In Commercial Distribution

  • 00859105006130 ()


  • Inhaler dose sensor
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