Catalog Number

-

Brand Name

CARESCAPE

Version/Model Number

Central Station v1 upgrade

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133882

Product Code

BSE

Product Code Name

ANALYZER, GAS, HELIUM, GASEOUS-PHASE

Public Device Record Key

084bd710-ed6c-47eb-b5ef-505c1e8f1946

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

June 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-