Catalog Number

CVS61110

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

d86b3cbc-6992-4e36-ae79-3f278f6a3b7b

Public Version Date

November 26, 2021

Public Version Number

1

DI Record Publish Date

November 18, 2021

Package DI Number

M991CVS611102

Quantity per Package

8

Contains DI Package

M991CVS611101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box