Catalog Number

220449

Brand Name

ambIT

Version/Model Number

220449

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"

-

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

5843b2e8-51d2-4050-8f9e-61cfb07b202a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Package DI Number

20857595005279

Quantity per Package

5

Contains DI Package

00857595005275

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-