CarePath

GUDID 00860003114711

MALE Urine Flow Device

Cleartrac Technologies, LLC

Urine flowmeter, reusable

• Primary Device ID: 00860003114711
• NIH Device Record Key: 91b8b701-ec6e-4640-81de-70a56c05d685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarePath
• Version Model Number: DCD-001M
• Company DUNS: 082296929
• Company Name: Cleartrac Technologies, LLC
• Device Count: 16
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003114711 [Unit of Use]
GS1	10860003114718 [Primary]

FDA Product Code

• EXY: Uroflowmeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [CarePath]

• 00860003114742: Base Station (Charger)
• 00860003114735: MALE Urine Flow Disposable
• 00860003114728: FEMALE Urine Flow Disposable
• 00860003114711: MALE Urine Flow Device
• 00860003114704: FEMALE Urine Flow Device