MedX Rehab Console

GUDID 00628451918288

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

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 00628451918288
• NIH Device Record Key: 5a21b9ed-b194-4f5c-b025-918444f0812a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedX Rehab Console
• Version Model Number: 1100N
• Company DUNS: 202128257
• Company Name: MedX Health Corp
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 29 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 29 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 29 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 29 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 29 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 29 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 29 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Humidity: Between 29 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628451918103 [Direct Marking]
GS1	00628451918288 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-07
• Device Publish Date: 2018-10-17

Devices Manufactured by MedX Health Corp

• 00628451918189 - MedX Home Unit - Light Therapy system: 2019-05-07 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 m
• 00628451918226 - MedX Rehab Portable Laser: 2019-05-07 The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery p
• 00628451918103 - MedX Rehab Console System: 2019-05-07 The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical condition
• 00628451918288 - MedX Rehab Console: 2019-05-07The 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.
• 00628451918288 - MedX Rehab Console: 2019-05-07 The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical device accessories like the Multi-cluster, teth
• 00628451918295 - MedX SLD Light Cluster: 2019-05-07 The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapp
• 00628451918301 - MedX Rehab Tethered Laser: 2019-05-07 The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (
• 00628451918240 - MedX Laser Portable, tethered: 2019-05-07 The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for MedX Health item numbers #3120 and #312
• 00628451918165 - MedX Home Console: 2019-05-07 The MedX Home console or MBM 2030 controls and provides power to MedX SLD cluster MCT 1000. It is the main reference for identif