Catalog Number

86-001641

Brand Name

DeRoyal

Version/Model Number

86-001641

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

e88a5680-37d7-4921-a660-ab72a789d2b4

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

July 12, 2021

Package DI Number

50749756265510

Quantity per Package

20

Contains DI Package

00749756265515

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case