Catalog Number

UTO255

Brand Name

N/A

Version/Model Number

UTO255

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

K052249,K052249

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

36ac9c6a-d359-490c-920d-3c572a1218b6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 03, 2017

Package DI Number

10607411945615

Quantity per Package

15

Contains DI Package

00607411945618

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-