Pain-x-2000

GUDID 00865198000313

Infrared Heating Device

DIOMEDICS LIGHT THERAPY INC

Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp

• Primary Device ID: 00865198000313
• NIH Device Record Key: fa24e081-eaac-459a-a5c5-381376fb4a95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pain-x-2000
• Version Model Number: Infrabed
• Company DUNS: 799055483
• Company Name: DIOMEDICS LIGHT THERAPY INC
• 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: true

Customer Support Contacts

• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com
• Phone: +1(888)972-4699
• Email: info@diomedics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865198000313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982546

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: 2018-07-06
• Device Publish Date: 2017-01-06

On-Brand Devices [Pain-x-2000]

• 00865198000320: Infrared Heating Device
• 00865198000313: Infrared Heating Device
• 00865198000306: Infrared Heating Device