CarePath System

Primary DI
00860010862209
Brand
CarePath System
Company
I/O Urology Corp.
Model
DCDUFD-001M
Device description
The CarePath system facilitates evaluations measuring urine output. It consists ofthe CarePath device, accompanying documents, and training. The system:• Measures and calculates flow rate and volume from urination data• Automatically transmits urination data to a secure location• Creates and provides uroflow reports to healthcare providersThe intended operator of the CarePath device is the patient. The CarePathsystem has no user-serviceable components. This system is not to be servicedor maintained by the user. The intended environments are hospitals, clinics,doctor’s offices and the patient’s home.
Published
2024-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00860010862209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010862209008600108622098600108622090860010862209

GMDN Terms#

Term, Definition table
TermDefinition
Urine flowmeter, reusableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119175980
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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