Catalog Number

-

Brand Name

Defibtech AirAware Remote ASI Cellular Module

Version/Model Number

DCM-U1613

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

OUG

Product Code Name

Medical Device Data System

Public Device Record Key

669fddc4-3996-43dd-8b1b-a2037a987f40

Public Version Date

April 09, 2019

Public Version Number

2

DI Record Publish Date

December 24, 2018

Package DI Number

10815098020703

Quantity per Package

1

Contains DI Package

00815098020706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-