Catalog Number

2N8395

Brand Name

CLEARLINK

Version/Model Number

2N8395

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

K924064,K924064

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

ca5956f2-afec-463d-b8bb-72152f734a05

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

50085412046414

Quantity per Package

200

Contains DI Package

00085412046419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE