Apnea Guard - Apnea Guard Device Kit Low (10) Spanish (V2) - ADVANCED BRAIN MONITORING, INC.

Duns Number:969842715

Device Description: Apnea Guard Device Kit Low (10) Spanish (V2)

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More Product Details

Catalog Number

-

Brand Name

Apnea Guard

Version/Model Number

AG25-1001.10(SPA)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Device Record Status

Public Device Record Key

a88bd3b7-51ed-45b0-a675-6de20c89c5ae

Public Version Date

October 05, 2021

Public Version Number

1

DI Record Publish Date

September 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED BRAIN MONITORING, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 140