AccessGUDID - DEVICE: CarePath (10860003114718)

GUDID

Device Identifier (DI) Information

Brand Name: CarePath
Version or Model: DCD-001M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Cleartrac Technologies, LLC

Primary DI Number: 10860003114718
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 16
Labeler D-U-N-S® Number*: 082296929 *Terms of Use

Device Description: MALE Urine Flow Device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXY	Uroflowmeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91b8b701-ec6e-4640-81de-70a56c05d685
Public Version Date: July 08, 2021
Public Version Number: 1
DI Record Publish Date: June 30, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00860003114711 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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