Q2 Multiport Extension Set - QUEST MEDICAL INC

Duns Number:041810693

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More Product Details

Catalog Number

95712

Brand Name

Q2 Multiport Extension Set

Version/Model Number

95712

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)

Yes

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

K800825,K800825

Product Code Details

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Device Record Status

Public Device Record Key

d8ce1cb6-5afa-4452-864e-8b247f5d88fb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

20634624957125

Quantity per Package

50

Contains DI Package

00634624957121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"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