Catalog Number

HCSNVAS

Brand Name

Medline

Version/Model Number

HCSNVAS

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

K102120

Product Code

CBK

Product Code Name

Ventilator, continuous, facility use

Public Device Record Key

e459b6a1-ec88-4b37-8a1b-2d474c641762

Public Version Date

April 05, 2022

Public Version Number

2

DI Record Publish Date

March 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-