Catalog Number

YM064

Brand Name

Arisure

Version/Model Number

YM064

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

50c92cb6-a58a-4578-843a-5a02d5e6fbdc

Public Version Date

June 03, 2019

Public Version Number

1

DI Record Publish Date

May 24, 2019

Package DI Number

10851891007206

Quantity per Package

25

Contains DI Package

00851891007209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser