Catalog Number

-

Brand Name

Waveline VS

Version/Model Number

60180V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113653

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

c9d3a40d-e75f-4cde-bcbc-777557bca45f

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

February 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-