Catalog Number

-

Brand Name

Apnea Guard

Version/Model Number

AG25-1012(SPA)

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

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

153320bb-332c-42d1-ae39-a65ced2605ce

Public Version Date

January 26, 2021

Public Version Number

1

DI Record Publish Date

January 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-