Catalog Number

-

Brand Name

Insulia

Version/Model Number

REdwing 1IUS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 26, 2019

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

-

For Single-Use

-

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

K170669

Product Code

NDC

Product Code Name

Calculator, Drug Dose

Public Device Record Key

d13339b4-744d-427f-a2a2-9c269201b51b

Public Version Date

October 24, 2022

Public Version Number

9

DI Record Publish Date

August 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-