Catalog Number

P001197

Brand Name

Battery Charger UK, Biim Ultrasound

Version/Model Number

P001197

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

K173138,K173138

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

32d7cbe0-901b-482d-ba34-75d90e5204fe

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 10, 2019

Package DI Number

07090045490242

Quantity per Package

1

Contains DI Package

07090045490273

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EA