Catalog Number

-

Brand Name

Waveline EZ-MAX

Version/Model Number

60145T10V

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

K131971

Product Code

CBQ

Product Code Name

Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

Public Device Record Key

a93f8743-aca4-4d51-a5b9-130f5318ab7c

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-