Catalog Number

-

Brand Name

UltraFlo Insulin Syringe

Version/Model Number

225931

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

5b531578-152a-48c8-b15d-19cba8a6aac2

Public Version Date

January 20, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2019

Package DI Number

B7442259313

Quantity per Package

6

Contains DI Package

B7442259312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton