BBS Revolution™ PD-010-0002

GUDID 00869209000200

The BBS Revolution™ device is an automated bladder volume measurement device.

DBMEDX INC.

Bladder volume ultrasound imaging system

• Primary Device ID: 00869209000200
• NIH Device Record Key: 19b42a46-81d2-49c0-83c5-7fa2a2165a9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BBS Revolution™
• Version Model Number: PD-010-0002
• Catalog Number: PD-010-0002
• Company DUNS: 827456927
• Company Name: DBMEDX 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: true
• 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: 720.515.6630
• Email: info@dbmedx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869209000200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142329

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2019-03-19
• Device Publish Date: 2019-03-11

Devices Manufactured by DBMEDX INC.

• 00860001971439 - Attendant® Prodigy™ Bladder Scanner: 2024-06-03 The BBS Revolution™ device is an automated bladder volume measurement device.
• 00869209000248 - BBS Revolution™ Rolling Stand: 2024-04-09
• 00869209000224 - dBsonx™: 2019-07-04 Single pack dBsonx ultrasound gel to be used with the BBS Revolution (TM) bladder scanner
• 00869209000200 - BBS Revolution™: 2019-03-19The BBS Revolution™ device is an automated bladder volume measurement device.
• 00869209000200 - BBS Revolution™: 2019-03-19 The BBS Revolution™ device is an automated bladder volume measurement device.
• 00869209000231 - AttendantⓇ Prodigy™ Bladder Scanner: 2019-03-19 The BBS Revolution™ device is an automated bladder volume measurement device.