Catalog Number

-

Brand Name

EXTENSION SET

Version/Model Number

EB-012-01

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

K955896,K955896

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

7a4f2148-300b-4162-a17b-aa72cfbda131

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

Package DI Number

10810080610238

Quantity per Package

50

Contains DI Package

00810080610231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case