Catalog Number

220332

Brand Name

ambIT

Version/Model Number

220332

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

-

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

07ab94ce-7187-4fdb-b20f-8ac8eb448215

Public Version Date

October 04, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20857595005132

Quantity per Package

40

Contains DI Package

10857595005135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-