CarePath

Basic Information

• Brand Name: CarePath
• Primary DI: 00860003114728
• Version / Model: UFD-001F
• Company Name: Cleartrac Technologies, LLC
• Labeler DUNS: 082296929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: 8b5e4f5d-c017-44dc-ab98-68d6cc9c794f

Device Description

FEMALE Urine Flow Disposable

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
32072	Urine flowmeter, single-use	A non-electrical device that is used to measure the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder. This device is a single-use device. This GMDN code may reflect old technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003114728	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius