Catalog Number

SYL213

Brand Name

N/A

Version/Model Number

SYL213

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K050171,K050171

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

184b047f-cef4-4292-a373-3c8775b15871

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2017

Package DI Number

10607411945516

Quantity per Package

32

Contains DI Package

00607411945519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-