Identity
- Trade Name
- Stream Dx FDA UDI
- Generic Name
- Urine flowmeter, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SDX02 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- SDX02 FDA UDI
- Primary DI / UDI-DI
- 00860412001565 FDA UDI
- FDA Product Code
- EXY FDA UDI
- GMDN Term
- Urine flowmeter, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine flowmeter, reusable
Stream Dx by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ZIEN Medical Technologies, LLC
Sources (1)
- FDA UDI 6744c38c-2440-46bb-9a6b-dbeb3de3042f 34 fields · synced May 31, 2026