FDA UDI
In Commercial Distribution
🇺🇸 United States
CarePath
DI: 10860003114701
·
Model: DCD-001F
·
Cleartrac Technologies, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
16
Basic Information
- Brand Name
- CarePath
- Primary DI
- 10860003114701
- Version / Model
- DCD-001F
- Company Name
- Cleartrac Technologies, LLC
- Labeler DUNS
- 082296929
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 16
- Record Status
- Published
- Publish Date
- 2021-06-30
- Public Version
- 1
- Public Version Date
- 2021-07-08
- Public Version Status
- New
- Public Device Record Key
- 60927dc4-fe13-480c-8f9c-270d96425e05
Device Description
FEMALE Urine Flow Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXY | Uroflowmeter | Gastroenterology, Urology | 876.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36337 | Urine flowmeter, reusable | A device that is used to measure the flow and volume of urine from a patient during the course of normal urination in order to identify micturation disturbances. The device is usually used by healthcare professionals who instruct the patient to empty their bladder into the measuring chamber of the device; some types may be designed to be used by laymen. This device may use mechanical, electrical, or a combination for the measuring techniques and provide digital measurements such as total voided volume, volume at maximum flow, maximum flow rate, mean flow rate, flow time, and time of maximum flow. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00860003114704 | GS1 | ||||
| Primary | 10860003114701 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius