Night Shift - Night Shift LE Device Kit - Spanish - ADVANCED BRAIN MONITORING, INC.

Duns Number:969842715

Device Description: Night Shift LE Device Kit - Spanish

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Night Shift

Version/Model Number

NS27-1005.LE(SPA)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140190

Product Code Details

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Device Record Status

Public Device Record Key

b93bcc3b-358e-4309-b996-961cb3873670

Public Version Date

May 05, 2021

Public Version Number

1

DI Record Publish Date

April 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED BRAIN MONITORING, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 140