Catalog Number

-

Brand Name

Neo-Pod T Circuit

Version/Model Number

9399

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

1221c9a8-41c5-4b2f-aae5-4d5b82f457e0

Public Version Date

November 08, 2019

Public Version Number

1

DI Record Publish Date

October 31, 2019

Package DI Number

10709078008181

Quantity per Package

20

Contains DI Package

00709078008184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-