Catalog Number

HCSNVAL

Brand Name

Medline

Version/Model Number

HCSNVAL

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,K102120

Product Code

CBK

Product Code Name

Ventilator, continuous, facility use

Public Device Record Key

bbe36971-5bf2-4fd5-a678-a05cc2ee66eb

Public Version Date

January 14, 2021

Public Version Number

1

DI Record Publish Date

January 06, 2021

Package DI Number

20193489021520

Quantity per Package

10

Contains DI Package

10193489021523

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE