Catalog Number

-

Brand Name

ADVANCED GAS-MACHINE ANESTHESIA

Version/Model Number

AM-6000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 29, 2028

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120075

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Public Device Record Key

06c92be6-1395-4076-9703-b1d8eacf1f77

Public Version Date

June 04, 2020

Public Version Number

1

DI Record Publish Date

May 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-