Catalog Number

-

Brand Name

Vapor Clean

Version/Model Number

10000

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"

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

K092031,K092031,K092031

Product Code

CBN

Product Code Name

Apparatus, Gas-Scavenging

Public Device Record Key

e7f968eb-04c5-40f8-85e0-f2e5ed304a55

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2017

Package DI Number

80858545007000

Quantity per Package

8

Contains DI Package

00858545007004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-