CUBEscan - The BioCon-500 is a portable ultrasound system - Mcube Technology Co., Ltd.

Duns Number:689866580

Device Description: The BioCon-500 is a portable ultrasound system for measuring the urine volume in a patient

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More Product Details

Catalog Number

-

Brand Name

CUBEscan

Version/Model Number

BioCon-500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

3ca243c5-39f3-4f60-8605-a4582f88e6b2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MCUBE TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6