Catalog Number

PSKITPROA

Brand Name

PureSleep Pro

Version/Model Number

PSKITPROA

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

K113022

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

690c294e-531f-40c4-b8ea-7409f4c653f0

Public Version Date

August 30, 2018

Public Version Number

1

DI Record Publish Date

July 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-