Fortitude

Basic Information

• Brand Name: Fortitude
• Primary DI: 00653599000830
• Version / Model: SG-0232
• Company Name: BIODERM, INC.
• Labeler DUNS: 114773653
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-10
• Public Version: 2
• Public Version Date: 2022-07-06
• Public Version Status: Update
• Public Device Record Key: d8318331-4676-4888-a826-c737a021527d
• Distribution End Date: 2022-07-05

Device Description

UreSil® Fortitude® Fixation Device, 3-32 Fr

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMK	Device, Intravascular Catheter Securement	General Hospital	880.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56631	Wearable percutaneous catheter/tube holder	A device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10653599000837	GS1	box	30	Not in Commercial Distribution	2022-07-05
Primary	00653599000830	GS1
Package	20653599000834	GS1	case	3	Not in Commercial Distribution	2022-07-05
Secondary	M456SG023251502	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius