Catalog Number

-

Brand Name

Pneupac

Version/Model Number

100/905/301-CH

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

K020899,K020899

Product Code

BTL

Product Code Name

Ventilator, emergency, powered (resuscitator)

Public Device Record Key

93b73d69-e4e1-4e0a-b81e-349a57829205

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

February 26, 2019

Package DI Number

35019517159602

Quantity per Package

10

Contains DI Package

15019517159608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton