Catalog Number

-

Brand Name

ULTRAFLO

Version/Model Number

281

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

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

5ce45972-ba75-470d-b571-b1aeecd81fdd

Public Version Date

July 23, 2020

Public Version Number

3

DI Record Publish Date

September 11, 2018

Package DI Number

60857182006007

Quantity per Package

10

Contains DI Package

50857182006000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS