Catalog Number

NM82130A-12

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

c27d4a32-426f-4c76-bfaf-d99ec7d923d2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

M991NM82130A123

Quantity per Package

4

Contains DI Package

M991NM82130A122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case