Catalog Number

-

Brand Name

Ventlab

Version/Model Number

SC300

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

K093525,K093525

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

8a961902-204f-41a0-becc-e15059507a73

Public Version Date

October 21, 2019

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

20889483109240

Quantity per Package

20

Contains DI Package

10889483109243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box