RENASYS® Y-Connector

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew Medical, Ltd.

Identity

Trade Name: RENASYS® Y-Connector FDA UDI
Generic Name: Negative-pressure wound therapy tubing set FDA UDI
Device Name: RENASYS Y-Connector US Non-sterile FDA UDI
Model / Reference: 66020971 FDA UDI
Description: RENASYS Y-Connector US Non-sterile FDA UDI

Identifiers

Catalog Number: 66020971 FDA UDI
Primary DI / UDI-DI: 05000223493592 FDA UDI
510(k) Number: K181204 FDA UDI
FDA Product Code: OMP FDA UDI
GMDN Term: Negative-pressure wound therapy tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4780 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Negative-pressure wound therapy tubing set

RENASYS® Y-Connector by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K181204 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: Smith & Nephew Medical, Ltd.

Sources (1)

FDA UDI e9c0fc49-9e47-4ae6-b80d-a7d2c4713272 35 fields · synced May 30, 2026