AccessGUDID - DEVICE: MEDCOMP GEN III POWER INJECTABLE PORT (00810988021207)

GUDID

Device Identifier (DI) Information

Brand Name: MEDCOMP GEN III POWER INJECTABLE PORT
Version or Model: JT150806101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: JET MEDICAL, INC.

Primary DI Number: 00810988021207
Issuing Agency: GS1
Commercial Distribution End Date: November 22, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079506014 *Terms of Use

Device Description: 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER

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: 3c7410e0-9dd7-4412-be98-ad810ebdf8fa
Public Version Date: December 05, 2019
Public Version Number: 6
DI Record Publish Date: February 13, 2018