Catalog Number

NM82230A

Brand Name

Clear-View MAX "Sub-Q" Infusion Set

Version/Model Number

ClearView™MAX

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

ab142124-8094-4858-9043-2ae61a920ebf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

M991NM82230A2

Quantity per Package

8

Contains DI Package

M991NM82230A1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box