AEROSIZER®

Basic Information

• Brand Name: AEROSIZER®
• Primary DI: 00884450031117
• Version / Model: 00884450031117
• Catalog Number: 90129-501/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: 2016-10-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4c385f40-3760-46e8-a943-b197c093aabf

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: MR Conditional
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDY	DEVICE, MEASURING, FOR PANENDOSCOPE	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45679	Endoscopic measuring device, pulmonary stricture	A device used in conjunction with certain endoscopes (e.g., a rigid or flexible bronchoscope) to provide an atraumatic, direct measurement of the lumen and length of a pulmonary stricture for the indication of correct tracheobronchial stent selection. It is inserted through the working channel of the endoscope through which the physician views the site whilst operating this device to make the required measurements. It consists of a solid metal wire in a plastic sheath that terminates in expandable sizing arms at the distal end. The arms are operated by the physician through a syringe-like activation handle and a built-in indicator relates to the lumen diameter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884450031117	GS1