Epistat®

Basic Information

• Brand Name: Epistat®
• Primary DI: 00763000035709
• Version / Model: 1527031
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-29
• Public Version: 3
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: ca8a0fd2-74c0-4513-9776-0197897cd76e

Device Description

CATHETER 1527031 EPISTAT NASAL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMX	BALLOON, EPISTAXIS	Ear, Nose, Throat	874.4100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12699	Nasal haemostatic balloon	A device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000035709	GS1

Customer Contacts

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