Catalog Number

-

Brand Name

AC Adapter for NE-C803

Version/Model Number

C803AC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141140,K141140

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

59ba7e28-c0bc-46a8-8dfa-689b28472e40

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10073796803138

Quantity per Package

20

Contains DI Package

00073796803131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case