X-1 APD Cycler

FDA UDI

Class II (US FDA UDI)

by Byonyks Private Limited

Identity

Trade Name: X-1 APD Cycler FDA UDI
Generic Name: Peritoneal dialysis system FDA UDI
Device Name: The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis. FDA UDI
Model / Reference: 1B1207 FDA UDI
Description: The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis. FDA UDI

Identifiers

Catalog Number: 1B1207 FDA UDI
Primary DI / UDI-DI: 08964004471001 FDA UDI
FDA Product Code: FKX FDA UDI
GMDN Term: Peritoneal dialysis system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 15 Kilogram FDA UDI
Height — 255 Millimeter FDA UDI
Width — 410 Millimeter FDA UDI
Depth — 570 Millimeter FDA UDI

Category: Peritoneal dialysis system

X-1 APD Cycler by Byonyks Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Liberty® PDx — Fresenius Usa, Inc. · Class II
CloudCath Connect - Patient Monitoring Software — Gastroklenz Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Byonyks Private Limited

Sources (1)

FDA UDI 934872fb-c006-4d0d-846c-3a4261613faa 35 fields · synced May 30, 2026