NA

Basic Information

• Brand Name: NA
• Primary DI: 00385640023870
• Version / Model: EP-3000
• Company Name: Summit Medical, Inc.
• Labeler DUNS: 965484699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-11
• Public Version: 4
• Public Version Date: 2021-08-23
• Public Version Status: Update
• Public Device Record Key: 5d61cd18-9d19-41e0-9d00-86dd3432797c

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MJV	Device, Inflation, Middle Ear	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47542	Middle ear decompressor, positive pressure	A manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian tube, to counter/prevent certain physical states or thick fluid accumulation behind the eardrum. It typically consists of a manually-operated deflator/inflator (e.g., balloon) connected to an applicator (e.g., nosepiece, mouthpiece, face mask). This is a reusable device typically used in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385640023870	GS1

Premarket Submissions

Submission Number	Supplement Number
K073401	000