DBMEDX INC.

Address:10394 W Chatfield Ave,Littleton,CO,80127,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3) Transducer, Ultrasonic, Diagnostic (ITX) (2)

Premarket Exempt

No Yes

Clear

BBS Revolution™ - 00869209000200 Catalog Number : PD-010-0002

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

Device Class : 2

Duns Number: 827456927

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : No

Device Count : 1

dBsonx™ - 00869209000224 Catalog Number : PD-040-0014

Device Description : Single pack dBsonx ultrasound gel to be used with the BBS Revolution (TM) bladder scanner

Device Class :

Duns Number: 827456927

Premarket Exempt : Yes

Product Code : IYO

Prescription Use : No

Device Count : 1

AttendantⓇ Prodigy™ Bladder Scanner - 00869209000231 Catalog Number : PD-010-0007

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

Device Class : 2

Duns Number: 827456927

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : No

Device Count : 1

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