Catalog Number

-

Brand Name

Ventlab

Version/Model Number

CS9006

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

K040726,K040726

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

c5a51804-f826-4576-9579-5fe2812746a2

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

October 03, 2016

Package DI Number

20889483109820

Quantity per Package

25

Contains DI Package

10889483109823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box