MPS® Extension Tubing, 6 ft. x 1/8 in. - QUEST MEDICAL INC

Duns Number:041810693

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More Product Details

Catalog Number

7001104

Brand Name

MPS® Extension Tubing, 6 ft. x 1/8 in.

Version/Model Number

7001104

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

K953838,K953838

Product Code Details

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

81edc5d3-5c32-4233-8d08-96539e24f242

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

June 15, 2016

Additional Identifiers

Package DI Number

20634624701148

Quantity per Package

10

Contains DI Package

00634624701144

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