Catalog Number

-

Brand Name

Respiratory Shield

Version/Model Number

SFER-0S-1001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

b9294f1f-44e3-428b-b5de-dc8a1f5ef73c

Public Version Date

February 17, 2022

Public Version Number

1

DI Record Publish Date

February 09, 2022

Package DI Number

00860008240149

Quantity per Package

10

Contains DI Package

00860008240118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-