Catalog Number

-

Brand Name

Ventlab

Version/Model Number

SB100

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

K990098,K990098

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

b183744c-099d-43b0-b74d-86ca02bcab89

Public Version Date

October 21, 2019

Public Version Number

3

DI Record Publish Date

September 27, 2016

Package DI Number

20889483098636

Quantity per Package

25

Contains DI Package

10889483098639

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box