Catalog Number

220517Y

Brand Name

ambIT*

Version/Model Number

220517Y

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

K162165,K162165,K162165

Product Code

FRN

Product Code Name

Pump, infusion

Public Device Record Key

1d7d9130-e4d2-4979-a274-d8ed1b4cbcbb

Public Version Date

January 25, 2022

Public Version Number

1

DI Record Publish Date

January 17, 2022

Package DI Number

20193494001104

Quantity per Package

2

Contains DI Package

10193494001107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS