OptiMumm

Basic Information

• Brand Name: OptiMumm
• Primary DI: 20884524001088
• Version / Model: E3625
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-04-25
• Public Version Status: Update
• Public Device Record Key: 1a5d7ecb-bf70-40ac-986e-f4fcb2ba584c

Device Description

ULPA Filter

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FYD	APPARATUS, EXHAUST, SURGICAL	General, Plastic Surgery	878.5070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44979	Surgical plume evacuation system filter	A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884524001081	GS1	CASE	3	In Commercial Distribution
Primary	20884524001088	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K980915	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -29 – 149 Degrees Fahrenheit