Merit Medical Flow Control Switch™ - Merit Medical Systems, Inc.

Duns Number:184763290

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More Product Details

Catalog Number

U1SHC-Y

Brand Name

Merit Medical Flow Control Switch™

Version/Model Number

10884450293468

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

-

Product Code Details

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Device Record Status

Public Device Record Key

6696ea07-4dca-48de-8c0f-2b593ea59bcb

Public Version Date

March 02, 2021

Public Version Number

1

DI Record Publish Date

February 22, 2021

Additional Identifiers

Package DI Number

20884450293465

Quantity per Package

4

Contains DI Package

10884450293468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MERIT MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 573
2 A medical device with a moderate to high risk that requires special controls. 8779