Catalog Number

-

Brand Name

Disposable Respiratory Products, Neo-Pod T

Version/Model Number

9402U

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"

Yes

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

K870173,K870173

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

449532d2-0e20-4e1b-afb0-6eef4b483e9d

Public Version Date

October 26, 2018

Public Version Number

1

DI Record Publish Date

September 25, 2018

Package DI Number

10709078006002

Quantity per Package

20

Contains DI Package

00709078006005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-