M9/M11 Impact Dot Matrix Printer 9A259001

GUDID 00841709100154

The M9/M11 impact dot matrix printer records and prints critical sterilization cycle data, including chamber temperature and pressure, cycle elapsed times, and program cycle type.

MIDMARK CORPORATION

Ink printer

• Primary Device ID: 00841709100154
• NIH Device Record Key: 957fdbf2-4742-4a90-8871-bf3d4f8539de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M9/M11 Impact Dot Matrix Printer
• Version Model Number: 9A259001
• Catalog Number: 9A259001
• Company DUNS: 005036025
• Company Name: MIDMARK CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-(800)634-6289
• Email: telemarketing@midmark.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841709100154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023348

FDA Product Code

• FLE: Sterilizer, Steam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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