BREEZE® SECUREMENT

Basic Information

• Brand Name: BREEZE® SECUREMENT
• Primary DI: 00884908140798
• Version / Model: BL0512
• Catalog Number: BL0512
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-26
• Public Version: 1
• Public Version Date: 2022-03-07
• Public Version Status: New
• Public Device Record Key: b741f9be-ae8e-42c1-a0bb-f1d3ce061bd5

Device Description

BREEZE® DRAIN LOCK 5F -12F

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
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	50884908140793	GS1	box	8	In Commercial Distribution
Package	30884908140799	GS1	inner box	25	In Commercial Distribution
Primary	00884908140798	GS1

Customer Contacts

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