FDA.reportPublic FDA data

CT3000 Pro Base Unit

Primary DI
00890477000326
Brand
CT3000 Pro Base Unit
Company
SRS Medical Systems, Inc.
Model
900-040
Published
2020-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EXQCystometer, Electrical Recording
FENDevice, Cystometric, Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXQCystometer, Electrical RecordingGastroenterology, Urology2
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00890477000326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00890477000326008904770003268904770003260890477000326

GMDN Terms#

Term, Definition table
TermDefinition
CystometerA device used to examine the bladder, providing measurement data concerning pressure and volume. This data will be used for diagnostic evaluation of the neuromuscular mechanisms of the bladder. It may also measure the amount of residual urine after the patient has passed water. The device may operate mechanically, by ultrasound techniques, or a combination of both. For more advanced diagnosis/study of the bladder see the appropriate GMDN code.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796263598
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00890477000395Tri-Electrode Surface EMG730-0032026-03-04
00089047700395Tri-Electrode Surface EMG730-0032026-03-04
00890477000371EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)35700015S2026-01-21
00890477000388EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)35700015S2026-01-21
00890477000364EasyFlo Console900-0442023-04-26
00890477000166Discovery Base Unit900-0102018-06-25
00890477000074Insight Discovery Thermal 900-0342021-08-20
00890477000081Insight Discovery PWP900-0362021-08-20
00890477000104Insight Discovery Dual Inclinometer900-024-22021-08-20
00890477000159Insight Discovery Algometer900-015-22021-08-20
00890477000173Insight Discovery PWP (w/cable)900-0232021-08-20
00890477000180EMG Sensor900-0262021-08-20
00890477000296Insight Discovery Thermal (w/cable)900-014-22021-08-20
00890477000098Insight Discovery EMG900-0372021-08-19
00890477000210UDS Pump213852021-08-20
00890477000142CT3000 Base Unit900-0272021-08-19
00890477000203Uroflow Scale900-0352021-08-19
00890477000258CT3000 ScaleCT3-022021-08-19
00890477000357UroFlow Scale900-0422021-08-17
00890477000333UroCuff-DC Disposable, Single730-0022020-09-29

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08032248490130AtmosDELTA MED SPAEXQ2025-09-02
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