Catalog Number

-

Brand Name

Service gas

Version/Model Number

GAS-0812

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

K041548,K071672,K101690,K151329,K041548,K071672,K101690,K151329

Product Code

DPZ

Product Code Name

Oximeter, Ear

Public Device Record Key

ad2a90a4-1da3-46e0-89e9-17dfe163a2cc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

17640121880053

Quantity per Package

6

Contains DI Package

07640121880056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box