Q2® Needleless injection site - QUEST MEDICAL INC

Duns Number:041810693

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More Product Details

Catalog Number

3150

Brand Name

Q2® Needleless injection site

Version/Model Number

3150

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

7747d307-18cf-4c92-91bf-9437af3950e2

Public Version Date

September 23, 2019

Public Version Number

4

DI Record Publish Date

March 09, 2017

Additional Identifiers

Package DI Number

10634624031507

Quantity per Package

50

Contains DI Package

00634624031500

Package Discontinue Date

-

Package Status

-

Package Type

Carton

"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