Catalog Number

165200

Brand Name

Mouthseal, Disposable, Blue Thermoplastic IPPB

Version/Model Number

Mouthseal,Blue Thermoplastic IPPB - 165200

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

693317cc-cbc8-422b-9203-39106b469e99

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

January 13, 2020

Package DI Number

00817081024272

Quantity per Package

50

Contains DI Package

00817081024265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-