Catalog Number

500-0034-02

Brand Name

WVSM Wireless Vital Signs Monitor

Version/Model Number

WVSM RWC + miniCap

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

K191989

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

851e6068-3aea-4109-ac88-89a524b229e1

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-