Catalog Number

466423

Brand Name

LTV

Version/Model Number

466423

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

K031745

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

1c64013e-a23e-47b3-a2a2-ef1cbb74dbcf

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-