Catalog Number

500-0025-03

Brand Name

WVSM Wireless Vital Signs Monitor

Version/Model Number

WVSM SurgeCase/10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101674,K130957

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

5da9d1f2-dc40-4179-aba5-39c049920b20

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

December 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-