Elation™

Basic Information

• Brand Name: Elation™
• Primary DI: 00884450197974
• Version / Model: 00884450197974
• Catalog Number: P10L20
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 4
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: a1a6e3c4-a9d2-444c-b782-0247af2ffb9a

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: No
• 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
KTI	BRONCHOSCOPE ACCESSORY	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17827	Bronchial balloon catheter	A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884450197971	GS1		5	In Commercial Distribution
Primary	00884450197974	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Balloon Length-2 cm
Device Size Text, specify			Balloon Outer Diameters-10 mm, 11 mm, 12 mm
Device Size Text, specify			Catheter Length-100 cm