Peritoneal Dialysis

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Peritoneal Dialysis FDA UDI
Generic Name: Peritoneal catheter stylet FDA UDI
Model / Reference: 00884450462782 FDA UDI

Identifiers

Catalog Number: CSS-362 FDA UDI
Primary DI / UDI-DI: 00884450462782 FDA UDI
FDA Product Code: FKX FDA UDI
GMDN Term: Peritoneal catheter stylet 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

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

Yes

FDA UDI

Category: Peritoneal catheter stylet

Learn about the Peritoneal Dialysis device, a type of medical device used to filter and clean fluid from the blood in individuals with end-stage renal disease. This comprehensive device is designed for automatic delivery, making it easy to administer dialysis sessions at home. With its thin wire/rod design and single-use nature, this device requires careful handling and sterilization to ensure patient safety.

Similar devices

Also classified as Peritoneal catheter stylet.

Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Guardia — COOK INCORPORATED · Class II
Ritus — Mozarc Medical US LLC · Class II
Opus® — Medtronic PS Medical · Class II
Stylet — Medionics International , Ltd. · Class I

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: Merit Medical Systems, Inc.

Sources (1)

FDA UDI a0de78ad-7753-4ffd-9b26-267093cc1057 33 fields · synced Jul 11, 2026