Catalog Number

165860

Brand Name

ndd Spirette Breathing Tube

Version/Model Number

ndd Spirette Breathing Tube - 165860

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

104d0925-a36d-43b2-8890-fc9e2184c272

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

January 14, 2020

Package DI Number

00817081024456

Quantity per Package

200

Contains DI Package

00817081024449

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-