| Primary Device ID | 00869209000224 |
| NIH Device Record Key | e1cfb619-22fb-4618-aac5-af86096dfe35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | dBsonx™ |
| Version Model Number | PD-040-0014 |
| Catalog Number | PD-040-0014 |
| Company DUNS | 827456927 |
| Company Name | DBMEDX INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com | |
| Phone | 720.515.6630 |
| info@dbmedx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869209000224 [Primary] |
| GS1 | 20869209000228 [Package] Package: Case [400 Units] In Commercial Distribution |
| ITX | Transducer, Ultrasonic, Diagnostic |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-07-04 |
| Device Publish Date | 2016-08-04 |
| 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™ | 2019-07-04Single pack dBsonx ultrasound gel to be used with the BBS Revolution (TM) bladder scanner |
| 00869209000224 - dBsonx™ | 2019-07-04 Single pack dBsonx ultrasound gel to be used with the BBS Revolution (TM) bladder scanner |
| 00869209000200 - BBS Revolution™ | 2019-03-19 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. |