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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1.8m (70") with Anatomical Mask Size 1
FLEXICARE MEDICAL LIMITED
NF-157U
Not in Commercial Distribution

  • 00854401006525 ()


  • Ventilator breathing circuit, single-use
1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 1
FLEXICARE MEDICAL LIMITED
NF-157-1U
Not in Commercial Distribution

  • 00854401006501 ()


  • Ventilator breathing circuit, single-use
1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0
FLEXICARE MEDICAL LIMITED
NF-157-0U
Not in Commercial Distribution

  • 00854401006488 ()


  • Ventilator breathing circuit, single-use
Confort Flo Humidification System with
TELEFLEX INCORPORATED
IPN913729
Not in Commercial Distribution

  • 44026704659355 ()
  • 34026704659358 ()
  • 14026704659354 ()
2414

  • Ventilator breathing circuit, single-use
COMFORT FLO Humidification System
TELEFLEX INCORPORATED
IPN913728
Not in Commercial Distribution

  • 44026704659348 ()
  • 34026704659341 ()
  • 14026704659347 ()
2410

  • Ventilator breathing circuit, single-use
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
MED3272
In Commercial Distribution

  • 00851962007725 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
P-2040
In Commercial Distribution

  • 00851962007718 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
MED3373
In Commercial Distribution

  • 00851962007701 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft irrigation fluid warmer
ENTHERMICS, INC.
EC1540
In Commercial Distribution

  • 00851962007695 ()


  • Multi-purpose warming cabinet, stationary
modular fluid warmer
ENTHERMICS, INC.
MEDIVNOW
In Commercial Distribution

  • 00851962007572 ()


  • Multi-purpose warming cabinet, stationary
No Description
CORVENT MEDICAL, INC
Patient Circuit Kit
In Commercial Distribution

  • 00850057117332 ()
  • 00850057117172 ()
91-101-US304

  • Ventilator breathing circuit, single-use
The DASH® Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases.
Nuclein, LLC
DASH-0002
In Commercial Distribution

  • 00850063063005 ()
SG-0002

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Digital Dry Bath
AWARENESS TECHNOLOGY, INCORPORATED
2200
In Commercial Distribution

  • 00850229007089 ()


  • Laboratory shaker
No Description
ENTHERMICS, INC.
EC1850BL
In Commercial Distribution

  • 00851962007312 ()


  • Multi-purpose warming cabinet, stationary
No Description
ENTHERMICS, INC.
EC350L
In Commercial Distribution

  • 00851962007305 ()


  • Multi-purpose warming cabinet, stationary
No Description
ENTHERMICS, INC.
EC250L
In Commercial Distribution

  • 00851962007237 ()


  • Multi-purpose warming cabinet, stationary
17.3 cu ft halo heat combination warmer
ENTHERMICS, INC.
EC1730BL
In Commercial Distribution

  • 00851962007077 ()


  • Multi-purpose warming cabinet, stationary
12.6 cu ft halo heat combination warmer
ENTHERMICS, INC.
EC1260BL
In Commercial Distribution

  • 00851962007060 ()


  • Multi-purpose warming cabinet, stationary
15.4 cu ft halo heat combination warmer
ENTHERMICS, INC.
EC1540BL
In Commercial Distribution

  • 00851962007053 ()


  • Multi-purpose warming cabinet, stationary
7.7 cu ft halo heat fluid warmer
ENTHERMICS, INC.
EC770L
In Commercial Distribution

  • 00851962007046 ()


  • Multi-purpose warming cabinet, stationary
3.9 cu ft halo heat fluid warmer
ENTHERMICS, INC.
EC390L
Not in Commercial Distribution

  • 00851962007039 ()


  • Conduction blood/fluid warmer
3.4 cu ft halo heat fluid warmer
ENTHERMICS, INC.
EC340L
Not in Commercial Distribution

  • 00851962007022 ()


  • Conduction blood/fluid warmer
2.3 cu ft halo heat fluid warmer
ENTHERMICS, INC.
EC230L
Not in Commercial Distribution

  • 00851962007015 ()


  • Conduction blood/fluid warmer
modular fluid warmer
ENTHERMICS, INC.
ivNow
In Commercial Distribution

  • 00851962007008 ()


  • Multi-purpose warming cabinet, stationary
FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
BIOFIRE DEFENSE, LLC
COMP-SUB-0034
In Commercial Distribution

  • 00851458005297 ()
COMP-SUB-0034

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0002
In Commercial Distribution

  • 00851458005129 ()
NGDS-ASY-0002U

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
1.5
Not in Commercial Distribution

  • 00851458005112 ()
FLM1-ASY-0121

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0002
In Commercial Distribution

  • 00851458005051 ()
NGDS-ASY-0002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished Brace Direct Cryotherapy Machine – Advanced Cold Therapy for Faster Recovery Experience the power of cold therapy with our refurbished Brace Direct Cryotherapy Machine. Expertly restored for peak performance, it helps relieve post-surgical pain, arthritis, muscle spasms, and sports injuries. Compact, quiet, and easy to use—your go-to for faster recovery and lasting relief.
BRACE ALIGN LLC
UCTY194-2
In Commercial Distribution

  • 00860011821847 ()


  • Circulating-fluid localized thermal therapy system
Water circulating hot or cold pack.
Ermi LLC
THR
In Commercial Distribution

  • 00860011691501 ()


  • Circulating-fluid localized thermal therapy system
The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the microprocessor and control algorithm that continually assesses temperature input from tubing thermistors and regulates the energy provided to the tubing heating elements in the proximal and/or distal segments to reach and maintain temperature between 100.4°F (38°+/- 2°C) at patient delivery. The Controller receives power when connected to the Battery and modulates the energy flow to the TIS/TTS-B. The Quantum Controller has two connections, one for the battery and one for the Thermal Tubing of choice. The connection to the battery is an omni-directional plug for ease of insertion and the connection is safe and secure. The connection to the TIS or TTS-B is bi-directional and simple to execute- it’s plug and play. The Controller has LED lights on the shoulder of the device to inform the user about the output temperature and flow of the fluid. It will visually alert the care provider to the status of the system. The Controller is reusable and comes fitted with a Jacket that permits the mating (connection) of the TIS or TTS-B Life Warmer tubing circuit connector to the connector slot on the Controller.
NORTH AMERICAN RESCUE, LLC
63-5901
In Commercial Distribution

  • 00868058000447 ()
35-0003

  • Conduction blood/fluid warmer
The Lifewarmer Quantum Charger from is an AC-powered reusable device that can fully charge the Quantum Battery rapidly and safely. The Charger has built-in algorithms to ensure proper, steady charging without overcharging or damaging the health and integrity of the battery. The Battery can go from nearly 0% to full within 90 minutes. The Life Warmer Charger has two colored LED lights to inform the provider of the status of charge and condition of the battery. The Quantum Battery Charger connects to the Battery via an omni-directional plug that allows for rapid energy transfer while prioritizing safety even in cases of hasty disconnection. The Quantum Battery will alert the user if there is any issue associated with the health of the battery. The Charger comes supplied with a 6-foot AC power cord.
NORTH AMERICAN RESCUE, LLC
63-5905
In Commercial Distribution

  • 00868058000430 ()
35-0002

  • Conduction blood/fluid warmer
The LifeWarmer Quantum Battery is an extremely powerful and intelligent battery in a small, lightweight package- weighing only 16 oz. The Quantum Battery powers the whole warming system with state-of-the-art Lithium Polymer cells harnessing 44 Volts of electrical potential. The battery, 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 100.4°F (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. The Quantum Battery is built for use in the most austere and tactical environments. It is IP67 rated for water resistance and is the only portable fluid warming battery that has a disable feature on the audible alarm for tactical considerations. The Quantum Life Warmer Battery is rechargeable with a service life of 500 charge/discharge cycles. It is important to keep the Quantum Battery charged and ready for use. Always re-charge after deployment, even if the battery was not fully discharged. The battery can be kept plugged into the Quantum Charger, as the intelligent Battery senses charge demand and will charge as needed but never overcharge. The Battery has a “Status” button to check the state of charge at any moment, with 3 colored LEDs to inform the user about the condition of the battery.
NORTH AMERICAN RESCUE, LLC
63-5902
In Commercial Distribution

  • 00868058000423 ()
35-0001

  • Conduction blood/fluid warmer
The LifeWarmer Quantum Thermal Infusion Set (TIS) is the revolutionary IV tubing set that allows for safe, rapid warming of IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard IV 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 IV 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 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 approximately 1700 mL of 20C IV solution to a set point of 100.4F (38 +/- 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
63-5903
In Commercial Distribution

  • 00868058000461 ()
  • 00868058000409 ()
35-0004

  • Conduction blood/fluid warmer
Venclose Perforator Catheter
VENCLOSE INC
VC056F
In Commercial Distribution

  • 00858254006404 ()
  • 00858254006398 ()
  • 00858254006411 ()


  • Peripheral vascular electrocautery catheter, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm, 10 pack
VENCLOSE INC
VC-10A2.5-6F-100 [10X]
Not in Commercial Distribution

  • 00858254006190 ()

  • Length: 100 Centimeter


  • Peripheral vascular electrocautery catheter, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 10 pack
VENCLOSE INC
VC-10A2.5-6F-60 [10X]
In Commercial Distribution

  • 00858254006183 ()

  • Length: 60 Centimeter


  • Peripheral vascular electrocautery catheter, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm, 5 pack
VENCLOSE INC
VC-10A2.5-6F-100 [5X]
In Commercial Distribution

  • 00858254006176 ()

  • Length: 100 Centimeter


  • Peripheral vascular electrocautery catheter, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 5 pack
VENCLOSE INC
VC-10A2.5-6F-60 [5X]
In Commercial Distribution

  • 00858254006169 ()

  • Length: 60 Centimeter


  • Peripheral vascular electrocautery catheter, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm
VENCLOSE INC
VC10A256F100
In Commercial Distribution

  • 00858254006015 ()
  • 00858254006206 ()
  • 00858254006220 ()

  • Length: 100 Centimeter


  • Peripheral vascular electrocautery catheter, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm
VENCLOSE INC
VC10A256F60
In Commercial Distribution

  • 00858254006008 ()
  • 00858254006213 ()
  • 00858254006237 ()

  • Length: 60 Centimeter


  • Peripheral vascular electrocautery catheter, single-use
Contains: (1) Breathing Circuit (1) Water Chamber (1) Water Chamber Adaptor
Telesair, Inc.
HBCK01
In Commercial Distribution

  • 00860009312296 ()
  • 10860009312293 ()


  • Ventilator breathing circuit, single-use
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 Blood and Fluid Warming System 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 TTS-B (Thermal Transfusion Set - Blood) NOTE: TTS-B is Single Use Only, Supplied sterile via Ethylene Oxide
NORTH AMERICAN RESCUE, LLC
63-5900
In Commercial Distribution

  • 00868058000485 ()
35-0006

  • Conduction blood/fluid warmer
No Description
ICU MEDICAL, INC.
100/905/361
In Commercial Distribution

  • 45019315079215 ()
  • 15019315079214 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/360
In Commercial Distribution

  • 45019315079208 ()
  • 15019315079207 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/341
In Commercial Distribution

  • 35019315076118 ()
  • 15019315076114 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/340
In Commercial Distribution

  • 35019315076101 ()
  • 15019315076107 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/302
In Commercial Distribution

  • 35019315061084 ()
  • 15019315061080 ()


  • Ventilator breathing circuit, single-use
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