Midmark

Basic Information

• Brand Name: Midmark
• Primary DI: 00841709109591
• Version / Model: 9A401002
• Catalog Number: 9A401002
• Company Name: MIDMARK CORPORATION
• Labeler DUNS: 005036025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-15
• Public Version: 1
• Public Version Date: 2020-12-23
• Public Version Status: New
• Public Device Record Key: 2a76f797-3019-43b8-bc40-b67cf8037fd9

Device Description

The M3 printer is optimal for mechanical monitoring of each cycle. Records and prints critical sterilization cycle data, including chamber temperature and pressure, cycle elapsed times, and program cycle type.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
FLE	Sterilizer, steam	General Hospital	880.6880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38450	Ink printer	A colour or monochrome printer designed to propel droplets of ink directly onto a medium (typically paper) to produce a printed image.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709109591	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090670	000