Catalog Number

-

Brand Name

Respire Pink+ Hard

Version/Model Number

SPP000US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 23, 2018

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

K131138

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

f4fe8807-01ef-4960-944d-7865c58f2750

Public Version Date

February 17, 2020

Public Version Number

6

DI Record Publish Date

September 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-