T3 TRIPLE LUMEN - 15.5F X 28CM T-3 TRIPLE LUMEN CT FULL TRAY - Medical Components, Inc.

Duns Number:038000253

Device Description: 15.5F X 28CM T-3 TRIPLE LUMEN CT FULL TRAY

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More Product Details

Catalog Number

-

Brand Name

T3 TRIPLE LUMEN

Version/Model Number

MC013524

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 24, 2020

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NIE

Product Code Name

CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Device Record Status

Public Device Record Key

44ce830f-3a1a-44d3-9944-5c8c5a69d3ac

Public Version Date

February 05, 2021

Public Version Number

7

DI Record Publish Date

March 02, 2016

Additional Identifiers

Package DI Number

50884908092726

Quantity per Package

5

Contains DI Package

00884908092721

Package Discontinue Date

June 24, 2020

Package Status

Not in Commercial Distribution

Package Type

box

"MEDICAL COMPONENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2560