Catalog Number

-

Brand Name

AIPHONE

Version/Model Number

NHR-SP.E

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IQA

Product Code Name

System, Environmental Control, Powered

Public Device Record Key

84f9c76b-8a38-459d-82fe-cac97e7b9a56

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-