Hickman Trifusion Catheter - Hickman TriFusion 12F with Intermediate Tray - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: Hickman TriFusion 12F with Intermediate Tray

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More Product Details

Catalog Number

0619190

Brand Name

Hickman Trifusion Catheter

Version/Model Number

0619190

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"

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

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Device Record Status

Public Device Record Key

85d6aed4-82d7-43b8-b23e-9d1d604bf7c1

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 11, 2015

Additional Identifiers

Package DI Number

10801741098212

Quantity per Package

5

Contains DI Package

00801741098215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"BARD ACCESS SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 3348
U Unclassified 8