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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No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI RIC RT
In Commercial Distribution

  • 00840388203330 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 CIC
In Commercial Distribution

  • 00840388202906 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI MRIC R
In Commercial Distribution

  • 00840388202869 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI RIC 312
In Commercial Distribution

  • 00840388201244 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI RIC 312
In Commercial Distribution

  • 00840388201237 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI MRIC R
In Commercial Distribution

  • 00840388201206 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI MRIC R
In Commercial Distribution

  • 00840388201190 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI RIC RT
In Commercial Distribution

  • 00840388201169 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI RIC RT
In Commercial Distribution

  • 00840388201152 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI BTE R
In Commercial Distribution

  • 00842318177384 ()
63122P2

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
The Lifewarmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) is a Game-Changing innovation that has succeeded in closing a critical capability gap previously left exposed by other commercial off-the-shelf fluid warmers currently fielded. Size, weight, performance, and ease of use are no longer collective barriers to the delivery of whole blood in far forward and near point of injury (POI) prehospital casualty management. The Quantum exceeds all healthcare and logistical requirements for the delivery of warmed blood or fluids across the defined spectrum of care. The system consists of unique thermal administration sets that incorporate sensing elements with an integrated heating system that does not disrupt the fluid path. With advanced intelligence throughout the system, the lightweight Controller modulates and moderates the energy flow to the integrated heating elements to ensure consistent normothermic fluid delivery to the casualty. The 44V battery is the smallest in category, able to rapidly adjust power distribution based on the temperature and flow rate of the input fluid. This creates a highly efficient system capable of previously unrealized performance optimizations. The Quantum system has an operational weight of just 22 total ounces yet can deliver two units of 39°F Whole Blood (WB) at 100mL/min with an output temperature of 100.4°F (38°+/- 2°C) with only a 24 second warm-up period. The Quantum Blood and Fluid Warming System provides the Tactical Health Care Professional with significant technological overmatch in the fight to eliminate preventable combat death. Quantum System Contents: 1 x Controller 1 x Battery 1 x Battery Charger 2 x TIS (Thermal Infusion Set) NOTE: TIS is Single Use Only, Supplied sterile via Ethylene Oxide and Not Intended for use with Blood and Blood Products
NORTH AMERICAN RESCUE, LLC
63-5906
In Commercial Distribution

  • 00868058000492 ()
35-0007

  • Conduction blood/fluid warmer
The LifeWarmer Quantum Thermal Transfusion Set- Blood is the revolutionary IV tubing set that allows for safe, rapid warming of blood, blood products, or IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard blood infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard blood tubing, there is almost no additional equipment burden. The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors (thermal resistors) located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery. The Quantum Life Warmer, fully charged, is able to warm and maintain up to 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4F (38+/- 2C) at a flow rate of 100 mL/min (depending on the ambient temperature). Or, approximately 1700 mL of 20C IV solution to a set point of 38C +/- 2C at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.
NORTH AMERICAN RESCUE, LLC
63-5904
In Commercial Distribution

  • 00868058000454 ()
  • 00868058000416 ()
35-0005

  • Conduction blood/fluid warmer set
The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of: • enrolling a patient for an ECG monitoring session in a medical facility, • receiving the signal from a compatible monitoring device worn by the patient, • using an external AI service for signal analysis and classification, • processing signal and annotations received from the external AI service, including statistics computation, • reviewing the signal and annotations by an ECG Technician, • generating and publishing reports for single ECG episodes and the entire monitoring session as well, • reviewing published reports back at the medical facility that ordered the monitoring session in the first place.
MEDICALGORITHMICS S A
DeepRhythm Platform
In Commercial Distribution

  • 05903021560698 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 2400 BTE 13
In Commercial Distribution

  • 00842318174383 ()
63096-A

  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1000 BTE 13
In Commercial Distribution

  • 00842318174307 ()
63095-A

  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1200 BTE 13
In Commercial Distribution

  • 00842318174215 ()
63094-A

  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1600 BTE 13
In Commercial Distribution

  • 00842318174130 ()
63093-A

  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 2000 BTE 13
In Commercial Distribution

  • 00842318174062 ()
63092-A

  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318173430 ()
63085-J

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318173416 ()
63085-A

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318173409 ()
63085-8

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318173393 ()
63085-7

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
NUEAR CIRCA AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318173386 ()
63085-4

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318173379 ()
63085-2

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318173362 ()
63085-1

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1000 RIC 312
In Commercial Distribution

  • 00842318173331 ()
63084-A

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1200 RIC 312
In Commercial Distribution

  • 00842318173249 ()
63083-A

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 1600 RIC 312
In Commercial Distribution

  • 00842318173164 ()
63082-A

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXSLIV AI 2000 RIC 312
In Commercial Distribution

  • 00842318173096 ()
63081-A

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIOSYNC VIA AI 2400 BTE 13
In Commercial Distribution

  • 00842318172983 ()
63078-J

  • Air-conduction hearing aid, behind-the-ear
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