Catalog Number

TEAM3A-ENB-USA

Brand Name

SONICAID

Version/Model Number

TEAM3A-ENB-USA

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

K200975

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Public Device Record Key

9b063fd4-d875-4d40-b5df-ab810d793ecb

Public Version Date

November 24, 2021

Public Version Number

1

DI Record Publish Date

November 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-