Merit Medical®

Basic Information

• Brand Name: Merit Medical®
• Primary DI: 00884450426340
• Version / Model: 00884450426340
• Catalog Number: IA-102/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: 2019-06-12
• Public Version: 1
• Public Version Date: 2019-06-20
• Public Version Status: New
• Public Device Record Key: 898998bd-2eab-4ffb-923d-c417e45e792f

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: 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
FCY	Bulb, inflation, for endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61354	Peritoneal dialysis catheter introduction set	A collection of sterile devices, which includes at least one invasive device, intended to assist percutaneous placement of a peritoneal dialysis catheter (not included). The kit includes devices intended to assist catheter insertion (e.g., dilators, insertion sheath) and may include additional non-dedicated catheterization support devices (e.g., dressings); it does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884450426347	GS1		5	In Commercial Distribution
Primary	00884450426340	GS1
Package	20884450426344	GS1		5	In Commercial Distribution