Catalog Number

220569

Brand Name

ambIT

Version/Model Number

220569

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

OFQ

Product Code Name

Anesthesia Kit

Public Device Record Key

b826235d-0c7d-4adb-99ae-dfde5a3019ef

Public Version Date

March 26, 2020

Public Version Number

1

DI Record Publish Date

March 18, 2020

Package DI Number

20850000509010

Quantity per Package

5

Contains DI Package

00850000509016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-