Catalog Number

2115-BULK

Brand Name

AMD-RITMED DISTECH

Version/Model Number

2115-BULK

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2017

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

5f1aa881-5df0-462b-af0e-32bcf376b260

Public Version Date

March 08, 2021

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-