Catalog Number

301.328.020

Brand Name

iFlow

Version/Model Number

301.328.020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BZO

Product Code Name

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Public Device Record Key

0491b20e-cac9-4b4f-b5a0-b670b6e23509

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

August 31, 2022

Package DI Number

07640149388954

Quantity per Package

10

Contains DI Package

07640149388985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE