Catalog Number

-

Brand Name

Nimbus II EpiD

Version/Model Number

Nimbus II EpiD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K153193,K153193,K153193

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

f71db85a-a8d7-4701-a189-d36f562af8e3

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

September 02, 2020

Package DI Number

10817170020373

Quantity per Package

1

Contains DI Package

00817170020376

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack