Catalog Number

-

Brand Name

Flow-i C30 Anesthesia System

Version/Model Number

6888530

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

K191027

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Public Device Record Key

0df00157-6f56-4e0e-a2d3-62bfe113ab7c

Public Version Date

June 03, 2020

Public Version Number

1

DI Record Publish Date

May 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-