Catalog Number

684175

Brand Name

TC-CSI-5P DTS INTFC CA CRITICARE SYSTEMS INC

Version/Model Number

684175

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

4d4ef70f-5da5-4fda-91c5-1e79f952d1e2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

50886333641753

Quantity per Package

1

Contains DI Package

00886333641758

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Zip Bag