LONG TERM CVC - 12F X 15CM SILICONE SINGLE LUMEN CATHETER SET - Medical Components, Inc.

Duns Number:038000253

Device Description: 12F X 15CM SILICONE SINGLE LUMEN CATHETER SET W/STYLET

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More Product Details

Catalog Number

-

Brand Name

LONG TERM CVC

Version/Model Number

SSL1215M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

8b021012-79d6-44da-87a9-64481a87ee43

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

June 15, 2016

Additional Identifiers

Package DI Number

50884908049515

Quantity per Package

10

Contains DI Package

00884908049510

Package Discontinue Date

January 29, 2021

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