Catalog Number

-

Brand Name

Beyond Sleep

Version/Model Number

667560060471

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LWF

Product Code Name

DILATOR, NASAL

Public Device Record Key

2d2c3c84-c4de-464f-94ef-e34b9e5e65c0

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

Package DI Number

10667560060478

Quantity per Package

36

Contains DI Package

00667560060471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box