Catalog Number

220562

Brand Name

ambIT

Version/Model Number

220562

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

158669dc-9ed9-45a9-8626-d4b25914ab97

Public Version Date

January 27, 2020

Public Version Number

1

DI Record Publish Date

January 17, 2020

Package DI Number

20857595005989

Quantity per Package

5

Contains DI Package

00857595005985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-