Catalog Number

-

Brand Name

Insulia

Version/Model Number

Redwing W_1.6_US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K172177

Product Code

NDC

Product Code Name

Calculator, Drug Dose

Public Device Record Key

1384c710-9146-4adf-80b9-88f5b406b4af

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

August 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-