FDA.reportPublic FDA data

Stream Dx

Primary DI
00860412001503
Brand
Stream Dx
Company
Zien Medical Technologies, LLC
Model
SDX01
Catalog number
SDX01
Device description
The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electronically record adult male patient voiding data to assist in the diagnosis of lower urinary tract disorders and is designed for home use. Stream Dx will calculate a patient's flow rate and their maximum voided volume based on the collected data. This information will be provided to the caregiver by Stream Dx. The data obtained from the Stream Dx Uroflowmeter is meant to be used exclusively as a tool to aid in diagnosis of a condition. It is not intended to be used alone as the sole method of diagnosis.
Published
2023-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EXYUroflowmeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXYUroflowmeterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860412001503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860412001503008604120015038604120015030860412001503

GMDN Terms#

Term, Definition table
TermDefinition
Urine flowmeterAn electronic device intended to be used to measure the flow and volume of urine from a patient during the course of normal urination in order to identify micturition disturbances. It is usually operated by healthcare personnel who instruct the patient to empty their bladder into the measuring chamber of the device; some types may be operated by the patient at home. It may employ mechanical and/or electrical measurements of parameters such as total voided volume, volume at maximum flow, maximum flow rate, mean flow rate, flow time, and time of maximum flow; it may provide digital or printed data. This is a reusable device.

Regulatory Flags#

DUNS number
017535668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009800663GleanBright Uro, IncEXY2026-07-29
00860009800670GleanBright Uro, IncEXY2026-07-29
00199874903484Emano FlowEmano Metrics Inc.EXY2026-06-16
00086000980061GleanBright Uro, IncEXY2025-09-23
00860009800601GleanBright Uro, IncEXY2025-09-23
00860009800632GleanBright Uro, IncEXY2025-09-23
00860009800649GleanBright Uro, IncEXY2025-09-23
00860009800656GleanBright Uro, IncEXY2025-09-23
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07290019239246FIZE kUO Disposable KitFIZE RESEARCH LTDEXY2025-04-28
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