TUBING ORGANIZER - NON-STERILE

Basic Information

• Brand Name: TUBING ORGANIZER - NON-STERILE
• Primary DI: B066311033NS1
• Version / Model: 311033NS
• Catalog Number: 311033NS
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2015-10-13
• Public Version: 3
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: c6f4e25c-8d70-4899-8c71-439046e2660e

Device Description

A small, non-sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device intended to be sterilized prior to use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	870.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62137	Medical/surgical interventional tube/cable securement clip, single-use	A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B066311033NS3	HIBCC	INNER BAG	100	In Commercial Distribution
Primary	B066311033NS1	HIBCC
Unit of Use	B066311033NS0	HIBCC

Customer Contacts

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