Catalog Number

-

Brand Name

BIO MED

Version/Model Number

R219P62-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 06, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040484

Product Code

CCL

Product Code Name

Analyzer, Gas, Oxygen, Gaseous-Phase

Public Device Record Key

4c00a172-061e-496b-9c4f-8ca7840ae46b

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

September 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-