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
BIOSYNERGY, INC.
6000
Not in Commercial Distribution

  • M74460002 ()
  • M74460001 ()
  • M74460000 ()


  • Laboratory thermometer
No Description
BIOSYNERGY, INC.
5000
Not in Commercial Distribution

  • M74450002 ()
  • M74450001 ()
  • M74450000 ()


  • Laboratory thermometer
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-056529-00
In Commercial Distribution

  • 06936415919153 ()


  • Carbon dioxide sensor/cable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-056531-00
In Commercial Distribution

  • 06936415919061 ()


  • Carbon dioxide sensor/cable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-034114-00
In Commercial Distribution

  • 06936415912604 ()


  • Carbon dioxide sensor/cable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-053712-00
In Commercial Distribution

  • 06936415902759 ()


  • Carbon dioxide sensor/cable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-049134-00
In Commercial Distribution

  • 06936415902742 ()


  • Carbon dioxide sensor/cable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-053711-00
In Commercial Distribution

  • 06936415902674 ()


  • Carbon dioxide sensor/cable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-049136-00
In Commercial Distribution

  • 06936415902636 ()


  • Carbon dioxide sensor/cable
Small AirLife SeeBreath CO2Detector
AIRLIFE
2K8086
In Commercial Distribution

  • 50190752156041 ()
  • 10190752156043 ()
2K8086

  • Carbon dioxide sensor/cable
Large AirLifeSeeBreath CO2Detector
AIRLIFE
2K8085
In Commercial Distribution

  • 50190752156034 ()
  • 10190752156036 ()
2K8085

  • Carbon dioxide sensor/cable
KIT,ET-CO2 MODULE W/SOFTWARE
Carefusion Corporation
16920
Not in Commercial Distribution

  • 10846446012705 ()
16920

  • Carbon dioxide sensor/cable
Capnostat 5 Reusable ETCO2 Sensor
Carefusion Corporation
27695-001
Not in Commercial Distribution

  • 10846446063240 ()
27695-001

  • Carbon dioxide sensor/cable
Airlife™ Small AirLife SeeBreath CO2 Detector
Carefusion Corporation
2K8086
Not in Commercial Distribution

  • 50885403185739 ()
  • 10885403185731 ()
2K8086

  • Carbon dioxide sensor/cable
Airlife™ Large AirLife SeeBreath CO2 Detector
Carefusion Corporation
2K8085
Not in Commercial Distribution

  • 50885403185722 ()
  • 10885403185724 ()
2K8085

  • Carbon dioxide sensor/cable
CAPNOSTAT CO Sensor
Carefusion Finland 320 Oy
412340-002
Not in Commercial Distribution

  • 10885403256998 ()
412340-002

  • Carbon dioxide sensor/cable
Capnography Sensor Reusable For 980 Series Ventilator
Covidien LP
10087409
In Commercial Distribution

  • 10884521659100 ()


  • Carbon dioxide sensor/cable
DENTURE ID MICROCHIP DENTURE ID MICROCHIP
CMP INDUSTRIES LLC
D1EN
In Commercial Distribution

  • M482D1EN0 ()


  • Radio-frequency identification patient positioning/tracking system
KIT, BABY CARE NORTHSIDE 1/EA, 40/CS
Asp Global, LLC
NSBK001
In Commercial Distribution

  • 00840216108226 ()
  • 10840216108223 ()


  • Infant care kit
Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Product number: 35000 Primary DI number: 4260649160213) - Laser protection goggles (Product number: 32010 Primary DI number: 4260649160305) - LN Tape (Product number: 40100 Primary DI number: 4260649160466) - Self adhesive applicator (Product number: 40510 Primary DI number: 4260649160404) - LN Tip caps (Product number: 40710 Primary DI number: 4260649160503) - Set of silicon pads (Product number: 40600; Primary DI number: 4260649160312) - Silicone applicators (Product number: 40410; Primary DI number: 4260649160411)
Laserneedle GmbH
12000-Trolley
In Commercial Distribution

  • 04260649160046 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX SLD Light diode Cluster, with an output power of 500mW, is used together with the Richmar console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated. This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
MedX Health Corp
MCT 507
In Commercial Distribution

  • 00628451918417 ()
  • 00628451918400 ()
  • 60628451918419 ()
  • 20628451918411 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals. This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
MedX Health Corp
0455
In Commercial Distribution

  • 00628451918387 ()
  • 00628451918394 ()
  • 90628451918397 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser medical device accessory and is part of MedX Health kit Item # 0915. The hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. ) This registration is to show the UDI for direct marking and primary packaging when this product shipped as a particular item, e.g. replacement or repaired unit, and not as a kit.
MedX Health Corp
LCS450
In Commercial Distribution

  • 00628451918356 ()
  • 00628451918226 ()


  • Musculoskeletal/physical therapy laser, professional
The Oralase Portable Laser, LPS200, delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. This device is the main reference for identification and traceability for MedX Health kit Item# 0910 This product is registered to show its UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
MedX Health Corp
LPS200
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918349 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX SLD Light diode Cluster is used together with the MedX Home console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated.
MedX Health Corp
MCT1000
In Commercial Distribution

  • 00628451918332 ()
  • 00628451918172 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Home console or MBM 2030 controls and provides power to MedX SLD cluster MCT 1000. It is the main reference for identification and traceability, and part of the kit for MedX item number #2130. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
2030
In Commercial Distribution

  • 00628451918165 ()
  • 00628451918325 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for MedX Health item numbers #3120 and #3122. It is controlled and powered by MedX Rehab Console MBM1100N. This product is registered for the purpose showing its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
201
In Commercial Distribution

  • 00628451918240 ()
  • 00628451918318 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (LLLT) device for use to treat a wide variety of medical conditions. It is also used for treating deeper tissue conditions. This accessory contains three SLD near-infrared laser light diodes for therapeutic applications and a visible LED guide light. It is part of the kit for MedX Health Items #3114, #3116. LCT 450 is controlled and powered by MedX Rehab console 1100N. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
450
In Commercial Distribution

  • 00628451918301 ()
  • 00628451918134 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapped to the body for “hands-free”, unattended treatment. The accessory contains a large number of Light emitting diodes that are used to treat a variety of medical conditions such as swelling, inflammation, pain, bruising, wound healing and many other medical conditions. This laser medical device accessory is controlled and powered by MBM 1100N. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
MedX Health Corp
1001
In Commercial Distribution

  • 00628451918295 ()
  • 00628451918110 ()
  • 20628451918299 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical device accessories like the Multi-cluster, tethered MCT1001, Laser cluster, tethered LCT450 and Laser probe, tethered LPT 201. It is the main reference for identification and traceability, and part of the kit for MedX Health Item numbers #3110, #3114, #3116, #3120, and #3122. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
MedX Health Corp
1100N
In Commercial Distribution

  • 00628451918288 ()
  • 00628451918103 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Oralase Console system is a therapeutic Low-Level Laser and Light therapy system for Oralase application. It features a handheld laser device, tethered to a console, which provides low level laser therapy to a smaller focused treatment area. The single near-infra-red laser diode tip has a visible LED guide light for pinpoint application. The MedX 1100N console powers the handheld laser therapy device.
MedX Health Corp
3122
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918264 ()
  • 50628451918269 ()
  • 30628451918265 ()
  • 20628451918268 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Oralase Console system is a therapeutic Low-Level Laser and Light therapy system for Oralase application. It features a handheld laser device which provides low level laser therapy to a smaller focused treatment area. The single near-infra-red laser diode tip has a visible LED guide light and can be used with either the intra-oral or extra-oral light guides. The MedX 1100N console powers the handheld laser therapy device and also two SLD accessories. The MedX SLD Light cluster accessory offers light therapy for broader treatment applications. This accessory can be strapped to the body for “hands-free” unattended treatment.
MedX Health Corp
3120
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918257 ()
  • 50628451918252 ()
  • 30628451918258 ()
  • 20628451918251 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0915
In Commercial Distribution

  • 00628451918226 ()
  • 00628451918233 ()
  • 70628451918232 ()
  • 40628451918231 ()
  • 50628451918238 ()
  • 30628451918234 ()
  • 20628451918237 ()

  • Weight: 113 Gram


  • Musculoskeletal/physical therapy laser, professional
The Acupuncture Portable Laser delivers high-quality auricular laser acupuncture therapy. The device features one GaAIAs near-infrared laser diode and three visible red LEDs and a special fiber optic light guide tip that deliver low level laser & light therapy to very small trigger points on the ear. The Acupuncture Portable Laser has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0912
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918219 ()
  • 50628451918214 ()
  • 30628451918210 ()
  • 20628451918213 ()

  • Weight: 190 Gram


  • Musculoskeletal/physical therapy laser, professional
The Oralase Portable Portable Laser delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. The device features one GaAIAs near-infrared laser diode and three visible red guide LEDs that deliver laser & light therapy. The Oralase Portable Laser has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0910
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918202 ()
  • 60628451918204 ()
  • 40628451918200 ()
  • 50628451918207 ()
  • 30628451918203 ()
  • 20628451918206 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Brand Light Therapy home unit is a light therapy system for home use. It is used by the patient to treat a variety of medical conditions such a chronic pain, swelling, inflammation, bruising, wound healing, and much more. The device utilizes an LED light diode cluster that contain a large number of red light diodes. The cluster can be attached to the skin surface with the velcro straps prior to beginning a treatment.
MedX Health Corp
2031
In Commercial Distribution

  • 00628451918189 ()
  • 00628451918165 ()
  • 50628451918184 ()
  • 30628451918180 ()
  • 20628451918183 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Console System is a therapeutic Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruising, wound healing and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers the high quality handheld laser therapy device and also two SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader treatment applications. This accessory can be strapped to the body for "hands-free" unattended treatment.
MedX Health Corp
3116
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918158 ()
  • 30628451918159 ()
  • 50628451918153 ()
  • 20628451918152 ()
  • 40628451918156 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruising, wound healing and many other conditions that require therapy. . The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM 1100N console powers the one (1) laser therapy device.
MedX Health Corp
3114
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918141 ()
  • 50628451918146 ()
  • 30628451918142 ()
  • 20628451918145 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruise and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers three SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader variety of applications. This Cluster accessories can be strapped to the body for "hands-free" unattended treatment.
MedX Health Corp
3110
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918127 ()
  • 50628451918122 ()
  • 30628451918128 ()
  • 20628451918121 ()
  • 10628451918124 ()


  • Musculoskeletal/physical therapy laser, professional
Therapeutic Laser System
Theralase Inc
TLC-1000
In Commercial Distribution

  • 00627987397499 ()


  • Musculoskeletal/physical therapy laser, professional
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