Catalog Number

2210J

Brand Name

NA

Version/Model Number

2210J

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

-

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

-

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

e4c6a009-595a-4972-86c4-f454ec7a1066

Public Version Date

April 08, 2019

Public Version Number

5

DI Record Publish Date

September 15, 2017

Package DI Number

00817688022350

Quantity per Package

9

Contains DI Package

00817688022343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-