AccessGUDID - DEVICE: PRO-FUSE® (00884908149005)

GUDID

Device Identifier (DI) Information

Brand Name: PRO-FUSE®
Version or Model: MRCTT80001OR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MRCTT80001OR
Company Name: Medical Components, Inc.

Primary DI Number: 00884908149005
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: 8F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT ChronoFlex®POLYURETHANE CATHETERCATHETER

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61494	Vascular port/catheter	A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LJT	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3b6ecd61-63fc-4fca-a815-2865b0030868
Public Version Date: June 24, 2021
Public Version Number: 2
DI Record Publish Date: November 07, 2019