Medistim VeriQ System - Medistim ASA

Duns Number:519521751

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More Product Details

Catalog Number

VQ4122

Brand Name

Medistim VeriQ System

Version/Model Number

VQ4122

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

K040228

Product Code Details

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Device Record Status

Public Device Record Key

85b173c5-0df5-4a72-9bc7-81178c76ad16

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDISTIM ASA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 129