Midmark

Basic Information

• Brand Name: Midmark
• Primary DI: 00841709100314
• Version / Model: 9A599001
• Catalog Number: 9A599001
• Company Name: MIDMARK CORPORATION
• Labeler DUNS: 005036025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-01
• Public Version: 1
• Public Version Date: 2019-08-09
• Public Version Status: New
• Public Device Record Key: 37bba2ce-f9e2-45df-a142-7d32b507e304

Device Description

Records and prints sterilization cycle data including time, chamber temperature, and pressure

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	00841709100314	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163337	000