Catalog Number

220501

Brand Name

ambIT*

Version/Model Number

220501

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

-

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

K162165

Product Code

FRN

Product Code Name

Pump, infusion

Public Device Record Key

d7c966e4-ee2e-4afe-b840-c943ae0e2624

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

February 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-