Catalog Number

220517

Brand Name

ambIT

Version/Model Number

220517

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"

Yes

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

ab6f5337-7e9a-4dc3-bc35-9b57f77bdcb2

Public Version Date

October 15, 2018

Public Version Number

4

DI Record Publish Date

August 09, 2017

Package DI Number

20857595005545

Quantity per Package

20

Contains DI Package

10857595005548

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-