Catalog Number

SI1784

Brand Name

Neurovirtual

Version/Model Number

Maxxi Snore 7ft Key connector

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

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

K191095

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

b5a7f73a-d78f-454e-9371-2b47844fa5ef

Public Version Date

April 10, 2020

Public Version Number

1

DI Record Publish Date

April 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-