Catalog Number

-

Brand Name

SealFlex

Version/Model Number

4-005520-00

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

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

K023683,K023683,K023683

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

2d359cf8-4149-4c86-a537-8f9d373123b1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 22, 2017

Package DI Number

20841470108186

Quantity per Package

100

Contains DI Package

00841470108182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-