Q2 High Flow Stopcock - QUEST MEDICAL INC

Duns Number:041810693

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More Product Details

Catalog Number

9652

Brand Name

Q2 High Flow Stopcock

Version/Model Number

STV01

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)

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

FMG

Product Code Name

Stopcock, I.V. Set

Device Record Status

Public Device Record Key

7e256092-8fe7-409f-b09a-d3924540ba22

Public Version Date

May 20, 2021

Public Version Number

1

DI Record Publish Date

May 12, 2021

Additional Identifiers

Package DI Number

20634624911011

Quantity per Package

100

Contains DI Package

00634624911017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"QUEST MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 168
U Unclassified 8