Catalog Number

163802

Brand Name

Mouthpiece, Disposable, 1.058" O.D., 2.625" L

Version/Model Number

Mouthpiece,1.058" O.D., 2.625" L - 163802

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"

-

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

BYP

Product Code Name

Mouthpiece, Breathing

Public Device Record Key

f11939e9-2a37-41f9-8cd1-a466432c77fc

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

January 13, 2020

Package DI Number

00817081024180

Quantity per Package

100

Contains DI Package

00817081024173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-