Catalog Number

82-2010030

Brand Name

DeRoyal

Version/Model Number

82-2010030

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

-

Product Code

OFP

Product Code Name

Anesthesia breathing circuit kit (adult & pediatric)

Public Device Record Key

71135199-3a42-4887-8f6f-b1fee238641c

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

July 12, 2021

Package DI Number

50749756135554

Quantity per Package

20

Contains DI Package

00749756135559

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case