Catalog Number

-

Brand Name

Ventlab

Version/Model Number

PRO-6123

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

-

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

cbee44c7-f2d0-4881-8131-eb0d77f5427d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2016

Package DI Number

20889483088279

Quantity per Package

20

Contains DI Package

10889483088272

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box