Catalog Number

-

Brand Name

Qitexio

Version/Model Number

QIT011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K203738,K203738,K203738

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

84af828a-109f-40ce-8ba6-8e05e0969e2f

Public Version Date

October 21, 2022

Public Version Number

1

DI Record Publish Date

October 13, 2022

Package DI Number

33700550400739

Quantity per Package

6

Contains DI Package

23700550400732

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton