Catalog Number

-

Brand Name

O2-RESQ

Version/Model Number

313-5094

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

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

-

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

eead04d0-7d39-4ff5-a801-10c7440cc2b7

Public Version Date

November 11, 2019

Public Version Number

5

DI Record Publish Date

June 30, 2017

Package DI Number

10841470109339

Quantity per Package

10

Contains DI Package

00841470109332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-