BluTab 2L Tablets

GUDID 00850018182003

PROEDGE DENTAL PRODUCTS, INC.

Medical device cleaning agent

• Primary Device ID: 00850018182003
• NIH Device Record Key: 6f95e519-722b-4575-a8e2-46a317da29fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BluTab 2L Tablets
• Version Model Number: BT20
• Company DUNS: 050414346
• Company Name: PROEDGE DENTAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• 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: 18888433343
• Email: richardv@proedgedental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018182003 [Primary]

FDA Product Code

• NRD: Unit, Operative Dental, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-28
• Device Publish Date: 2020-04-20

Devices Manufactured by PROEDGE DENTAL PRODUCTS, INC.

• 00850018182089 - BluTube 180 Day Cartridge: 2020-05-18 BluTube 180 Day Cartridge
• 00850018182072 - BluTube 90 Day Cartridge: 2020-05-18
• 00850018182003 - BluTab 2L Tablets: 2020-04-28
• 00850018182003 - BluTab 2L Tablets: 2020-04-28
• 00850018182010 - BluTab 750mL Tablets: 2020-04-28