Catalog Number

220418

Brand Name

ambIT

Version/Model Number

220418

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

BSO

Product Code Name

Catheter, Conduction, Anesthetic

Public Device Record Key

97ce1eec-abbd-4fb4-9431-86770f6b41b9

Public Version Date

October 15, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20857595005026

Quantity per Package

10

Contains DI Package

00857595005022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-