MUC-X

Basic Information

• Brand Name: MUC-X
• Primary DI: H671IM7088FR0
• Version / Model: 8 French
• Catalog Number: IM7088FR0
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Labeler DUNS: 094651270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-04
• Public Version: 1
• Public Version Date: 2020-06-12
• Public Version Status: New
• Public Device Record Key: 76b6b918-1a8c-4bb5-989d-e95d0da6592e

Device Description

MUC-X 8FR MUCOUS TRAP W/ WALL UNIT SUCTION ADAPTOR

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: Yes
• 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
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62605	ENT surgical aspirator	A sterile hand-held device intended to be used to aspirate fluid from a ENT cavity (e.g., middle ear) during a single surgical procedure. It typically consists of a flexible tube inserted into the cavity, a collection container and a connection to the wall outlet of a central vacuum system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H671IM7088FR0	HIBCC
Package	H671IM7088FR1	HIBCC		25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K893204	000