Catalog Number

302418

Brand Name

Pressure Valve

Version/Model Number

Pressure Valve

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

K963250,K963250

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

dd24f6b0-50d9-4e23-b4aa-55964807d308

Public Version Date

January 26, 2021

Public Version Number

4

DI Record Publish Date

July 18, 2017

Package DI Number

30606959002563

Quantity per Package

5

Contains DI Package

00606959002562

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

Multipack