AccessGUDID - DEVICE: Smart Port CT (H787CT96STSDVI1)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Port CT
Version or Model: CT96STSD-VI
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Angiodynamics, Inc.

Primary DI Number: H787CT96STSDVI1
Issuing Agency: HIBCC
Commercial Distribution End Date: July 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079252781 *Terms of Use

Device Description: Smart Port CT Single Titanium Port System with Attachable 9.6F x 66cm Silicone Catheter and 10 F Introducer Kit (with Valved Introducer)

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:	No
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
FPA	Set, administration, intravascular
LJT	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062414	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 9.6 French
Length: 66 Centimeter
Outer Diameter: 3.2 Millimeter
Lumen/Inner Diameter: 1.6 Millimeter

Device Record Status

Public Device Record Key: 35a2fa4e-6ae3-4204-85ae-7b59292eafc8
Public Version Date: July 23, 2024
Public Version Number: 8
DI Record Publish Date: September 17, 2015