Catalog Number

220514Y

Brand Name

ambIT

Version/Model Number

220514Y

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

d744439c-12d7-49f5-8466-160d6f8776b4

Public Version Date

December 23, 2019

Public Version Number

5

DI Record Publish Date

October 14, 2016

Package DI Number

20857595005101

Quantity per Package

20

Contains DI Package

10857595005104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-