Catalog Number

YM054

Brand Name

Arisure

Version/Model Number

YM054

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

1d840012-b446-450f-9255-1db216f972f9

Public Version Date

November 22, 2018

Public Version Number

1

DI Record Publish Date

October 22, 2018

Package DI Number

40851891007153

Quantity per Package

50

Contains DI Package

00851891007155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case