Catalog Number

-

Brand Name

Nimbus

Version/Model Number

Nimbus Hard Shell 100ml

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"

-

For Single-Use

Yes

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

7479b77b-628b-4904-b6ed-5306400ba2c1

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

January 15, 2019

Package DI Number

20817170020158

Quantity per Package

80

Contains DI Package

00817170020154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case