Catalog Number

-

Brand Name

NeoPod "T" 12VDC Power Supply Cable

Version/Model Number

9400

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

2e44b637-f73f-491a-81c1-5293fe1a876b

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

December 15, 2016

Package DI Number

10709078001915

Quantity per Package

1

Contains DI Package

00709078001918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-