Infusion Catheters - 14GA X 20CM SINGLE LUMEN INFUSION CATHETER SET - Medical Components, Inc.

Duns Number:038000253

Device Description: 14GA X 20CM SINGLE LUMEN INFUSION CATHETER SET

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More Product Details

Catalog Number

-

Brand Name

Infusion Catheters

Version/Model Number

CSP-1408

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 02, 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

0185529c-6e35-4ab9-8b1f-9465119c1d50

Public Version Date

August 03, 2021

Public Version Number

7

DI Record Publish Date

November 17, 2015

Additional Identifiers

Package DI Number

50884908007393

Quantity per Package

20

Contains DI Package

00884908007398

Package Discontinue Date

August 02, 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