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ViSi

FDA UDI

Class II (US FDA UDI)

by Sotera Wireless

Identity

Trade Name
ViSi FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
ViSi Cuff Module is an accessory intended for use together with the ViSi Mobile Monitor to measure noninvasive blood pressure (NIBP) of adult patients (18 years or older). FDA UDI
Model / Reference
Cuff Module FDA UDI
Description
ViSi Cuff Module is an accessory intended for use together with the ViSi Mobile Monitor to measure noninvasive blood pressure (NIBP) of adult patients (18 years or older). FDA UDI

Identifiers

Catalog Number
92-10011 FDA UDI
Primary DI / UDI-DI
00850733007018 FDA UDI
510(k) Number
K152341 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 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: General-purpose multi-parameter bedside monitor

ViSi by Sotera Wireless — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Cleared under the same submission

K152341 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sotera Wireless

Sources (1)

  • FDA UDI 3562352e-67f5-408e-a273-ae0021e4f707 36 fields · synced Jun 1, 2026