VersiPD

FDA UDI

Class II (US FDA UDI)

by Fresenius Usa, Inc.

Identity

Trade Name: VersiPD FDA UDI
Generic Name: Peritoneal dialysis system FDA UDI
Device Name: VersiPD Cycler FDA UDI
Model / Reference: 130821 FDA UDI
Description: VersiPD Cycler FDA UDI

Identifiers

Primary DI / UDI-DI: 00840861102198 FDA UDI
510(k) Number: K212522 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Peritoneal dialysis system

VersiPD by Fresenius Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peritoneal dialysis system.

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HomeChoice PRO APD System — BAXTER INTERNATIONAL INC. · Class II
HomeChoice APD System — BAXTER INTERNATIONAL INC. · Class II
CloudCath Connect - Patient Monitoring Software — Gastroklenz Inc. · Class II
CloudCath Drain Set - Fresenius Configuration — Gastroklenz Inc. · Class II
X-1 APD Cycler — BYONYKS PRIVATE LIMITED · Class II

Cleared under the same submission

K212522 also covers:

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: Fresenius Usa, Inc.

Sources (1)

FDA UDI 05846fd9-ff7f-45da-8ec8-62f2f2344db9 36 fields · synced Jun 1, 2026