Catalog Number

-

Brand Name

STAR 65

Version/Model Number

F3-86-390-1000-21

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K172147

Product Code

CBQ

Product Code Name

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

Public Device Record Key

1caeba52-bb33-40c4-9991-168a6d80143a

Public Version Date

February 01, 2022

Public Version Number

5

DI Record Publish Date

January 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-