Catalog Number

AMSR X1

Brand Name

Avaline Medical NJ LLC

Version/Model Number

AMSR X1

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"

Yes

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

-

Product Code

KHR

Product Code Name

ABSORBER, SALIVA, PAPER

Public Device Record Key

2a3be371-bdd5-4911-a052-05cc8e51e909

Public Version Date

December 13, 2021

Public Version Number

1

DI Record Publish Date

December 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-