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More Product Details

Catalog Number

-

Brand Name

Meraw

Version/Model Number

TMB-2084

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Prescription Use (Rx)

-

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

3776ff98-3cdc-4f95-ba9c-586244bb27d7

Public Version Date

September 12, 2022

Public Version Number

2

DI Record Publish Date

August 30, 2022

Additional Identifiers

Package DI Number

16932825300021

Quantity per Package

20

Contains DI Package

06932825300451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GUANGDONG TRANSTEK MEDICAL ELECTRONICS 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. 12