Catalog Number

17527-001

Brand Name

LTV

Version/Model Number

17527-001

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101643

Product Code

CBK

Product Code Name

Ventilator, continuous, facility use

Public Device Record Key

030c8d45-5d1f-4ffe-93e2-9a729ea75c5e

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

February 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-