Catalog Number

165700

Brand Name

Mouthpiece, Disposable For SP-150 Sensor

Version/Model Number

Mouthpiece, Disposable For SP-150 Sensor - 165700

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

7899f0b9-08e1-490d-873c-b7e6aa52f132

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

January 13, 2020

Package DI Number

00817081024333

Quantity per Package

10

Contains DI Package

00817081024326

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-