Catalog Number

L2EU01IB

Brand Name

NightBalance

Version/Model Number

00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180608,K180608

Product Code

MYB

Product Code Name

Pillow, cervical (for mild sleep apnea)

Public Device Record Key

8a2d87ca-3e4f-4d13-a4f9-b5e05ca7b544

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

30606959059581

Quantity per Package

30

Contains DI Package

00606959059580

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multipack