Catalog Number

1012-9650-000

Brand Name

Carestation 650

Version/Model Number

A1

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

K151570

Product Code

BSZ

Product Code Name

Gas-machine, anesthesia

Public Device Record Key

33a38dc5-1e5d-4694-93ff-ac9c8386291f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-