AccessGUDID - DEVICE: Xcela (H965451280)

GUDID

Device Identifier (DI) Information

Brand Name: Xcela
Version or Model: H965451280
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NAVILYST MEDICAL, INC.

Primary DI Number: H965451280
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809699023 *Terms of Use

Device Description: 8F x 750mm Xcela Plastic Power Injectable Port with Pre-Attached Polyurethane Catheter

Device Characteristics

What MRI safety information does the labeling contain?	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):	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
LJT	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072481	000
K073210	000

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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 750 Millimeter
Lumen/Inner Diameter: 1.6 Millimeter
Outer Diameter: 2.6 Millimeter
Catheter Gauge: 8 French
Needle Gauge: 17 Gauge

Device Record Status

Public Device Record Key: d2a94f62-771b-4f49-afb1-52d15fa7adcd
Public Version Date: February 11, 2022
Public Version Number: 4
DI Record Publish Date: September 17, 2015