Allday Spray 2 pk - Allday Spray 2 pk - ELEVATE ORAL CARE, LLC

Duns Number:002863526

Device Description: Allday Spray 2 pk

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More Product Details

Catalog Number

-

Brand Name

Allday Spray 2 pk

Version/Model Number

626000210

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150074

Product Code Details

Product Code

LFD

Product Code Name

Saliva, Artificial

Device Record Status

Public Device Record Key

1dfc18ad-5ac9-4774-9c42-ac5707bbb742

Public Version Date

May 06, 2022

Public Version Number

1

DI Record Publish Date

April 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELEVATE ORAL CARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 20
U Unclassified 5