Catalog Number

CVS12130NES

Brand Name

Clear-View Subcutaneous Infusion Set

Version/Model Number

Clear-View "Sub-Q"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K870188,K870188,K870188

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

8322f2ca-b84a-408c-aabe-607857b34909

Public Version Date

August 02, 2018

Public Version Number

1

DI Record Publish Date

July 02, 2018

Package DI Number

M991CVS12130NES2

Quantity per Package

8

Contains DI Package

M991CVS12130NES1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box