Catalog Number

-

Brand Name

Apnea Guard

Version/Model Number

25-1003

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

K111110,K111110

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

58b041bc-9502-493c-9fda-388c17a5be01

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10851113007069

Quantity per Package

5

Contains DI Package

00851113007062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit of 5 AG High