Catalog Number

90020

Brand Name

ANEclear

Version/Model Number

2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K033028,K033028

Product Code

BYW

Product Code Name

Device, Rebreathing

Public Device Record Key

f3124d40-d5cd-48f9-bb4c-6ce48fa33cea

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

February 27, 2018

Package DI Number

10863034000326

Quantity per Package

20

Contains DI Package

00863034000329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case