Catalog Number

220573

Brand Name

ambIT

Version/Model Number

220573

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

cef00f1e-e787-4cf5-8629-d5f5398d067c

Public Version Date

May 01, 2020

Public Version Number

1

DI Record Publish Date

April 23, 2020

Package DI Number

20850000509041

Quantity per Package

5

Contains DI Package

00850000509047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-