Automated PD Set DS-1.B

Basic Information

• Brand Name: Automated PD Set DS-1.B
• Primary DI: 08964004471032
• Version / Model: 1F1501
• Catalog Number: 1F1501
• Company Name: BYONYKS PRIVATE LIMITED
• Labeler DUNS: 645843231
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-13
• Public Version: 1
• Public Version Date: 2025-11-21
• Public Version Status: New
• Public Device Record Key: 33a1e1f8-369c-476a-845f-4a33865d31cd

Device Description

This Byonyks Automated PD Set DS-1.B is compatible with the Byonyks X-1 APD Cycler.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35000	Peritoneal dialysis system tubing set	A sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08964004471049	GS1	Box	7	In Commercial Distribution
Primary	08964004471032	GS1