Catalog Number

ABI-300

Brand Name

simpleABI

Version/Model Number

ABI-300

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

-

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

K110628

Product Code

JAF

Product Code Name

Monitor, Ultrasonic, Nonfetal

Public Device Record Key

2b07d6ae-3747-4cd4-894b-098c6e44fdee

Public Version Date

July 09, 2018

Public Version Number

1

DI Record Publish Date

June 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-