Catalog Number

MPSK10

Brand Name

MediPines Gas Exchange Monitor Starter Kit

Version/Model Number

MPSK10

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"

Yes

For Single-Use

Yes

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

K180902,K180902

Product Code

BZL

Product Code Name

Computer, Oxygen-Uptake

Public Device Record Key

3f083d2e-fb64-45f8-a03a-8c22c45d8f0d

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

March 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-