H2H Rinse Line

Basic Information

• Brand Name: H2H Rinse Line
• Primary DI: 00896241002367
• Version / Model: 70-5827
• Company Name: NEPHROS, INC.
• Labeler DUNS: 120664557
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-21
• Public Version: 7
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: aaf06adc-752e-4590-bfd9-0cbd3b1d229a
• Distribution End Date: 2021-09-16

Device Description

H2H Rinse Line and packaging information

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62203	Haemodialysis water purification system washer-disinfector (thermal)	An electrically-powered unit intended to heat water and pump the hot water into the ringline/pipeline of a reverse-osmosis haemodialysis water purification system for cleaning and disinfection. It typically consists of a heater, pump, and connectors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10896241002364	GS1	Carton	80	Not in Commercial Distribution	2021-09-16
Primary	00896241002367	GS1

Premarket Submissions

Submission Number	Supplement Number
K112314	000