Dialyzer Dialysate QD to 3/8 in.NPT

Basic Information

• Brand Name: Dialyzer Dialysate QD to 3/8 in.NPT
• Primary DI: 00858293006793
• Version / Model: D300-0108
• Company Name: REPROCESSING PRODUCTS CORPORATION
• Labeler DUNS: 796083392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-30
• Public Version: 1
• Public Version Date: 2019-09-09
• Public Version Status: New
• Public Device Record Key: 088dff46-8800-4313-a660-eef4172ede95

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
MON	System, Hemodialysis, Remote Accessories	Gastroenterology, Urology	876.5820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34993	Haemodialysis dialysate central supply system	An assembly of devices intended to supply large-scale haemodialysis dialysate (concentrate and/or ready-to-use solution) to medical facility haemodialysis systems for preparation/mixing and/or direct use. The system is typically built into the facility and consists of a pump(s) which applies positive pressure at a pre-set rate to supply the solution, storage tank(s), connection pipe(s), pressure and/or quantity sensor(s), and a control panel.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858293006793	GS1