Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

83-000107

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K946044,K946044

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

01405032-3fb3-4490-a318-4f0a4ada20c2

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

September 12, 2016

Package DI Number

50749756138388

Quantity per Package

50

Contains DI Package

00749756138383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case