PEDIATRIC TUBING ORGANIZER - STERILE

Basic Information

• Brand Name: PEDIATRIC TUBING ORGANIZER - STERILE
• Primary DI: B0663110340000
• Version / Model: 311034-000
• Catalog Number: 311034-000
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-12
• Public Version: 3
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: bbe268b8-67c9-4ed9-a950-c1f8fd68fa87
• Distribution End Date: 2023-06-20

Device Description

A small, 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	870.4290	2

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	B0663110340007	HIBCC	PARTIAL CASE	30	Not in Commercial Distribution	2023-06-20
Primary	B0663110340000	HIBCC
Package	B0663110340006	HIBCC	PARTIAL CASE	20	Not in Commercial Distribution	2023-06-20
Package	B0663110340005	HIBCC	CASE	40	Not in Commercial Distribution	2023-06-20
Package	B0663110340003	HIBCC	INNER CARTON	10	Not in Commercial Distribution	2023-06-20