AccessGUDID - DEVICE: BioFlo (H965440280)

GUDID

Device Identifier (DI) Information

Brand Name: BioFlo
Version or Model: 44028
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NAVILYST MEDICAL, INC.

Primary DI Number: H965440280
Issuing Agency: HIBCC
Commercial Distribution End Date: September 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 809699023 *Terms of Use

Device Description: BioFlo Dual Port with Endexo Technology - Plastic Port with Filled Suture Holes and 8F 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":	No
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 [?]
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
Catheter Gauge: 8 French
Pressure: 300 Pound per Square Inch
Needle Gauge: 18 Gauge
Device Size Text, specify: Dual Lumen
Outer Diameter: 2.6 Millimeter
Length: 63 Centimeter

Device Record Status

Public Device Record Key: 6b95eb27-11c4-4a03-a113-4c50980ea4ed
Public Version Date: September 23, 2024
Public Version Number: 5
DI Record Publish Date: June 09, 2016