Medical Imaging Solutions Intl. - 2-200ml syringes, 1-60" Y coiled tubing, dual - MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY

Duns Number:005179271

Device Description: 2-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 large spikes UM

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More Product Details

Catalog Number

-

Brand Name

Medical Imaging Solutions Intl.

Version/Model Number

200109

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170279,K170279

Product Code Details

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

7d54efd8-ea83-44bf-b9c5-3878fbf5ce72

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 15, 2021

Additional Identifiers

Package DI Number

10850014500143

Quantity per Package

20

Contains DI Package

00850014500146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 37