Catalog Number

163503

Brand Name

Mouthpiece, Disposable Flex, 1.035" O.D., 2.625" L

Version/Model Number

Mouthpiece, Disposable Flex, 1.035" O.D., 2.625" L - 163503

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

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

b58377d3-7de8-4d5e-8838-929dc88a6907

Public Version Date

April 08, 2020

Public Version Number

1

DI Record Publish Date

March 31, 2020

Package DI Number

00817081026238

Quantity per Package

100

Contains DI Package

00817081026221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-