Catalog Number

-

Brand Name

Smart Sense Insulin Syringes

Version/Model Number

052912

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062702,K062702,K062702

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

91cec6d6-f062-458a-8eff-ae6c3b306e1d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10883967398147

Quantity per Package

30

Contains DI Package

00883967398140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper