Catalog Number

-

Brand Name

Onset

Version/Model Number

540-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 22, 2030

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYW

Product Code Name

Container, Liquid Medication, Graduated

Public Device Record Key

cc03ef3c-d612-4c91-ba25-7b2e703eea1d

Public Version Date

November 25, 2020

Public Version Number

1

DI Record Publish Date

November 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-