MBA™

Basic Information

• Brand Name: MBA™
• Primary DI: 00884450650707
• Version / Model: 00884450650707
• Catalog Number: MAP400/C
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-16
• Public Version: 1
• Public Version Date: 2022-11-24
• Public Version Status: New
• Public Device Record Key: ea5c28e7-6fa7-4035-b804-c44f9814572f

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: 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: 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
OEQ	Angiography/angioplasty kit	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36079	Haemostasis valve	A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884450650701	GS1		4	In Commercial Distribution
Package	10884450650704	GS1		25	In Commercial Distribution
Primary	00884450650707	GS1