X-1 APD Cycler 1B1207

GUDID 08964004471001

Peritoneal dialysis system

Primary Device ID	08964004471001
NIH Device Record Key	934872fb-c006-4d0d-846c-3a4261613faa
Commercial Distribution Status	In Commercial Distribution
Brand Name	X-1 APD Cycler
Version Model Number	1B1207
Catalog Number	1B1207
Company DUNS	645843231
Company Name	BYONYKS PRIVATE LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08964004471001 [Primary]

FKX	System, Peritoneal, Automatic Delivery

Steralize Prior To Use	false
Device Is Sterile	false

08964004471049 - Automated PD Set DS-1.B	2025-11-21 This Byonyks Automated PD Set DS-1.B is compatible with the Byonyks X-1 APD Cycler.
08964004471001 - X-1 APD Cycler	2025-09-16The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.
08964004471001 - X-1 APD Cycler	2025-09-16 The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.
08964004471025 - Automated PD Set DS-1	2025-09-16 This Byonyks Automated PD Set DS-1 is compatible with the Byonyks X-1 APD Cycler.