Catalog Number

-

Brand Name

Portex

Version/Model Number

100/905/302

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K123957,K123957

Product Code

BTL

Product Code Name

Ventilator, emergency, powered (resuscitator)

Public Device Record Key

8fb5738f-1947-4c07-af7b-0fcc884f5edc

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

March 12, 2020

Package DI Number

35019315061084

Quantity per Package

10

Contains DI Package

15019315061080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case