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RENASYS GO v2 HOME

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew Medical, Ltd.

Identity

Trade Name
RENASYS GO v2 HOME FDA UDI
Generic Name
Negative-pressure wound therapy system, battery-powered, reusable FDA UDI
Device Name
RENASYS GO Pump and power supply FDA UDI
Model / Reference
66801496 FDA UDI
Description
RENASYS GO Pump and power supply FDA UDI

Identifiers

Catalog Number
66801496 FDA UDI
Primary DI / UDI-DI
00040565126944 FDA UDI
510(k) Number
K152163 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system, battery-powered, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system, battery-powered, reusable

RENASYS GO v2 HOME by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system, battery-powered, reusable.

Cleared under the same submission

K152163 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew Medical, Ltd.

Sources (1)

  • FDA UDI 5ad54023-db74-47b9-9113-3eb54102f56d 35 fields · synced May 30, 2026