CloudCath Sensor (Sensing Hardware)

Basic Information

• Brand Name: CloudCath Sensor (Sensing Hardware)
• Primary DI: 00860006810283
• Version / Model: 01PD001
• Company Name: Gastroklenz Inc.
• Labeler DUNS: 081043696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-05
• Public Version: 1
• Public Version Date: 2022-08-15
• Public Version Status: New
• Public Device Record Key: 92c1a90d-fddc-4fee-9cd7-b3d97f6669d5

Device Description

Sensing Hardware

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11226	Peritoneal dialysis system	An assembly of devices consisting of functional units [e.g., a mains electricity (AC-powered) pump, solution mixer, monitor] intended to perform peritoneal dialysis, a treatment that removes fluid and metabolic wastes from the blood by infusing dialysate into the peritoneal cavity through a catheter and a disposable tubing system, and then removing the dialysate. Diffusion of metabolic wastes from the blood to the dialysate occurs within the abdominal cavity through the pores and intercellular channels of the peritoneum. The device may automatically control the flow of dialysate into and out of the abdominal cavity.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860006810214	GS1	Box	1	In Commercial Distribution
Primary	00860006810283	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]