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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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Care Continuum Chair - 00850043655008

The TPM Research model CCC-1000 Care Continuum Chair is a manual operator-propelled chair that is designed for transport and use of seated occupants with their associated medical equipment (including oxygen bottle or IV fluid bags). The product is equipped with an electronic positioning system that assists with occupant entry and exit.
Tpm Research, Inc.
CCC-1000
In Commercial Distribution

  • 00850043655008 ()


  • Stand-assistive attendant-only-propelled wheelchair

NIRA Pro+ - 00850020752454

The NIRA PRO+ is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO+ consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO+ is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
174-000
In Commercial Distribution

  • 00850020752454 ()


  • Dermatological laser beam guiding handpiece

NIRA Precision Laser - 00850020752126

The NIRA Precision Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
117-000
In Commercial Distribution

  • 00850020752126 ()


  • Dermatological laser beam guiding handpiece

NIRA PRO - 00850020752119

The NIRA PRO is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
151-000
In Commercial Distribution

  • 00850020752119 ()


  • Dermatological laser beam guiding handpiece

NA - 05415067029072

DRG EPG Kit Accessories
ADVANCED NEUROMODULATION SYSTEMS, INC.
7885
In Commercial Distribution

  • 05415067029072 ()
7885

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

ET20S™ - 05415067022325

Radiofrequency Generator
ST. JUDE MEDICAL, INC.
NT7209975
In Commercial Distribution

  • 05415067022325 ()
NT7209975

  • Percutaneous radio-frequency ablation system generator

Beurer - 00850003500676

SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, portable (with cuff 22-42 cm).
BEURER NORTH AMERICA, L.P.
BM50
In Commercial Distribution

  • 00850003500676 ()
668.80

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Vitalcontrol - 00850003500485

SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, portable (with cuff 22-42 cm).
BEURER NORTH AMERICA, L.P.
SBM52
In Commercial Distribution

  • 10850003500482 ()
  • 00850003500485 ()
668.10, 666.16

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Wi-Box™ - 05414734054164

Cable
ST. JUDE MEDICAL, INC.
PSU Kit
In Commercial Distribution

  • 05414734054164 ()
C12785

  • Electrical mains power cable

Wi-Box™ - 05414734054140

Signal Transceiver
ST. JUDE MEDICAL, INC.
AO Transmitter
In Commercial Distribution

  • 05414734054140 ()
C12783

  • Medical networking interface unit

Beurer - 00850003500041

Infrared Lamp
BEURER NORTH AMERICA, L.P.
IL51
In Commercial Distribution

  • 10850003500048 ()
  • 00850003500041 ()
Art.- No. 619.73

  • Musculoskeletal infrared phototherapy unit, non-wearable

Eon Mini™ - 05414734405324

Charger Accessory
ADVANCED NEUROMODULATION SYSTEMS, INC.
3720
In Commercial Distribution

  • 05414734405324 ()
3720

  • Noninvasive device battery charger

Eon Mini™ - 05414734405300

Eon Mini LE Charging System
ADVANCED NEUROMODULATION SYSTEMS, INC.
3722
In Commercial Distribution

  • 05414734405300 ()
3722

  • Noninvasive device battery charger

Eon Mini™ - 05414734402620

No Description
ADVANCED NEUROMODULATION SYSTEMS, INC.
3721
In Commercial Distribution

  • 05414734402620 ()
3721

  • Noninvasive device battery charger

SJM™ - 05414734402477

No Description
ADVANCED NEUROMODULATION SYSTEMS, INC.
3701
In Commercial Distribution

  • 05414734402477 ()
3701

  • Noninvasive device battery charger

Therm-X - 00850001096379

Therm-X Butterfly Knee Small, SPU
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Butterfly Knee Small, SPU
In Commercial Distribution

  • 00850001096379 ()
TX0315

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096362

Therm-X Butterfly Knee Large, SPU
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Butterfly Knee Large, SPU
In Commercial Distribution

  • 00850001096362 ()
TX0314

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096355

Therm-X Hand Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Hand Garment
In Commercial Distribution

  • 00850001096355 ()
TX0112

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096348

Therm-X Half-Leg (Lower Leg) Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Half-Leg Garment
In Commercial Distribution

  • 00850001096348 ()
TX0111

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096324

Therm-X Hand SPU
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Hand SPU
In Commercial Distribution

  • 00850001096324 ()
TX0312

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096300

Therm-X XL Shoulder Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X XL Shoulder Garment
In Commercial Distribution

  • 00850001096300 ()
TX0110

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096294

Therm-X AT
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X AT
In Commercial Distribution

  • 00850001096294 ()
TX0002

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096287

Therm-X HOME
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X HOME
In Commercial Distribution

  • 00850001096287 ()
TX0300

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096270

Therm-X Extender Straps
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Extender Straps
In Commercial Distribution

  • 00850001096270 ()
TX0109

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096256

Therm-X Disposable Calf DVT Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Disposable Calf DVT Garment
In Commercial Distribution

  • 00850001096256 ()
  • 00850001096263 ()
TX0107

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096232

Therm-X Back SPU
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Back SPU
In Commercial Distribution

  • 00850001096232 ()
TX0305

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096225

Therm-X Hip SPU
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Hip SPU
In Commercial Distribution

  • 00850001096225 ()
TX0308

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096218

Therm-X Ankle SPU
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Ankle SPU
In Commercial Distribution

  • 00850001096218 ()
TX0304

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096201

Therm-X Knee SPU
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Knee SPU
In Commercial Distribution

  • 00850001096201 ()
TX0302

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096195

Therm-X Shoulder SPU
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Shoulder SPU
In Commercial Distribution

  • 00850001096195 ()
TX0301

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096188

Therm-X HOME
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X HOME
In Commercial Distribution

  • 00850001096188 ()
TX0300

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096171

Therm-X Hip Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Hip Garment
In Commercial Distribution

  • 00850001096171 ()
TX0108

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096089

Therm-X Foot DVT Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Foot DVT Garment
In Commercial Distribution

  • 00850001096089 ()
TX0106

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096072

Therm-X Calf DVT Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Calf DVT Garment
In Commercial Distribution

  • 00850001096072 ()
TX0107

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096065

Therm-X Shoulder Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Shoulder Garment
In Commercial Distribution

  • 00850001096065 ()
TX0101

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096058

Therm-X Elbow Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Elbow Garment
In Commercial Distribution

  • 00850001096058 ()
TX0103

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096041

Therm-X Ankle Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Ankle Garment
In Commercial Distribution

  • 00850001096041 ()
TX0104

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096034

Therm-X Knee Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Knee Garment
In Commercial Distribution

  • 00850001096034 ()
TX0102

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096027

Therm-X Back Garment
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Back Garment
In Commercial Distribution

  • 00850001096027 ()
TX0105

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096010

Therm-X AT
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X AT
In Commercial Distribution

  • 00850001096010 ()
TX0002

  • Inflatable hot/cold therapy pack/electric pump

Therm-X - 00850001096003

Therm-X Pro
ZENITH TECHNICAL INNOVATIONS, LLC
Therm-X Pro
In Commercial Distribution

  • 00850001096003 ()
TX0001

  • Inflatable hot/cold therapy pack/electric pump

Tablo(R) Hemodialysis System - 00850001011204

Tablo Console
Outset Medical, Inc.
PN-0006000
In Commercial Distribution

  • 00850001011204 ()


  • Haemodialysis system, institutional/home-use

EmbryoScope time-lapse incubator - 05712714603013

The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
Vitrolife A/S
ESD20000
In Commercial Distribution

  • 05712714603013 ()
ESD20000

  • Assisted reproduction incubator/microscope camera system

Equate - 00681131405898

No Description
WAL-MART STORES, INC.
HTD8813C
In Commercial Distribution

  • 10681131405895 ()
  • 00681131405898 ()
  • 20681131405892 ()
HTD8815US

  • Infrared patient thermometer, skin

IRRAflow® Drainage Collection System - 00868643000470

DCS 010 Drainage Collection System
Irras USA, Inc.
DCS 010
In Commercial Distribution

  • 10868643000477 ()
  • 00868643000470 ()
DCS 010

  • Intracerebral sensor catheter, short-term
  • Intracranial pressure monitor

VYAFUSER™ - 05713495000152

The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV
Phillips-Medisize A/S
VYAFUSER PUMP KIT US/PR A
In Commercial Distribution

  • 05713495001043 ()
  • 05713495000152 ()
  • 05713495000169 ()

  • Length: 6.7 Inch
  • Width: 3 Inch
  • Depth: 1.3 Inch
  • Weight: 285 Gram
2089870410

  • Ambulatory syringe pump

iTOF - 00860012119660

Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
NERBIO PRIVATE LIMITED
ITOFDEV01
In Commercial Distribution

  • 00860012119660 ()
  • 00860012119677 ()


  • Block-monitoring peripheral nerve electrical stimulation system

DispenSecur - 00860011977513

DispenSecur is a device intended for medical purposes to provide alerts and controlled patient access to medication based on dosing schedules predetermined by a healthcare provider. The device may be used with either liquid or solid dosage forms of one medication type. The device is not intended to manage multiple medications.
Verinetics Inc
1
In Commercial Distribution

  • 00860011977513 ()


  • Personal pill dose dispenser, electric

CarePath System - 00860010862209

The CarePath system facilitates evaluations measuring urine output. It consists of the CarePath device, accompanying documents, and training. The system: • Measures and calculates flow rate and volume from urination data • Automatically transmits urination data to a secure location • Creates and provides uroflow reports to healthcare providers The intended operator of the CarePath device is the patient. The CarePath system has no user-serviceable components. This system is not to be serviced or maintained by the user. The intended environments are hospitals, clinics, doctor’s offices and the patient’s home.
I/O Urology Corp.
DCDUFD-001M
In Commercial Distribution

  • 00860010862209 ()


  • Urine flowmeter, reusable

Continuous ECG Platform - 00860008259233

VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV350
In Commercial Distribution

  • 00860008259233 ()


  • Electrocardiography telemetric monitoring system
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