FDA.reportPublic FDA data

Leak Pnt Det, Single

Primary DI
00890477000289
Brand
Leak Pnt Det, Single
Company
SRS Medical Systems, Inc.
Model
LPD-3D
Published
2018-12-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EXQCystometer, Electrical Recording

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXQCystometer, Electrical RecordingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00890477000241PackageGS110In Commercial Distribution
00890477000289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00890477000241008904770002418904770002410890477000241
00890477000289008904770002898904770002890890477000289

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.

Regulatory Flags#

DUNS number
796263598
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
00890477000326CT3000 Pro Base Unit900-0402020-09-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890477000395Tri-Electrode Surface EMGSRS Medical Systems, Inc.EXQ2026-03-04
00089047700395Tri-Electrode Surface EMGSRS Medical Systems, Inc.EXQ2026-03-04
00890477000371EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)SRS Medical Systems, Inc.EXQ2026-01-21
00890477000388EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)SRS Medical Systems, Inc.EXQ2026-01-21
00086000980061GleanBright Uro, IncEXQ2025-09-23
00860009800601GleanBright Uro, IncEXQ2025-09-23
00860009800625GleanBright Uro, IncEXQ2025-09-23
00860009800632GleanBright Uro, IncEXQ2025-09-23
00860009800649GleanBright Uro, IncEXQ2025-09-23
00860009800656GleanBright Uro, IncEXQ2025-09-23
08032248487123AtmosDELTA MED SPAEXQ2025-09-02
08032248487147AtmosDELTA MED SPAEXQ2025-09-02
08032248487185Infusion SetDELTA MED SPAEXQ2025-09-02
08032248490130AtmosDELTA MED SPAEXQ2025-09-02
38032248487124AtmosDELTA MED SPAEXQ2025-09-02
08032248487130AtmosDELTA MED SPAEXQ2025-09-02
38032248487148AtmosDELTA MED SPAEXQ2025-09-02
38032248487186Infusion SetDELTA MED SPAEXQ2025-09-02
38032248490131AtmosDELTA MED SPAEXQ2025-09-02
E261MMT11730Infusion SetBIOENGINEERING LABORATORIES SRLEXQ2024-12-09
E261MMT11731Infusion SetBIOENGINEERING LABORATORIES SRLEXQ2024-12-09
E261UDA462150AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-10-10
E261UDA462151AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-10-10
08720648846083Flowsensor3-BTMedical Measurement Systems B.V.EXQ2024-09-17
E261UDA582450AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDAELN0AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDA582451AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDAELN1AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDA362050AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-02
E261UDA362051AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-02