Catalog Number

-

Brand Name

Apnea Guard

Version/Model Number

AG25-1009(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

cee5fe98-2fdb-4aad-9ef4-b15c4d50fd8a

Public Version Date

March 15, 2022

Public Version Number

1

DI Record Publish Date

March 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-