Automated PD Set DS-1

FDA UDI

Class II (US FDA UDI)

by Byonyks Private Limited

Identity

Trade Name: Automated PD Set DS-1 FDA UDI
Generic Name: Peritoneal dialysis system tubing set FDA UDI
Device Name: This Byonyks Automated PD Set DS-1 is compatible with the Byonyks X-1 APD Cycler. FDA UDI
Model / Reference: 1F1201 FDA UDI
Description: This Byonyks Automated PD Set DS-1 is compatible with the Byonyks X-1 APD Cycler. FDA UDI

Identifiers

Catalog Number: 1F1201 FDA UDI
Primary DI / UDI-DI: 08964004471018 FDA UDI
FDA Product Code: KDJ FDA UDI
GMDN Term: Peritoneal dialysis system tubing set 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Peritoneal dialysis system tubing set

Automated PD Set DS-1 by Byonyks Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 a93e59ac-fe87-4201-8e44-f79dd7b6bf1b 34 fields · synced Jun 8, 2026