Catalog Number

-

Brand Name

Pneupac

Version/Model Number

100/905/361

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

BYE

Product Code Name

Attachment, breathing, positive end expiratory pressure

Public Device Record Key

268e60df-807a-4740-85db-30873be95d44

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2015

Package DI Number

45019315079215

Quantity per Package

6

Contains DI Package

15019315079214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE