SpeedClean 002-0396-00

GUDID 00841709100208

MIDMARK CORPORATION

Steam sterilizer

• Primary Device ID: 00841709100208
• NIH Device Record Key: 14fbfb30-33f0-409b-b156-9efcb512335f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeedClean
• Version Model Number: 002-0396-00
• Catalog Number: 002-0396-00
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00841709100208 [Primary]
GS1	10841709100205 [Package]; Package: Box [12 Units]; In Commercial Distribution

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

Devices Manufactured by MIDMARK CORPORATION

• 00841709121326 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121333 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121340 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121357 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121364 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121371 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121388 - Midmark: 2024-04-30 Smart G-Vacuum-Base unit assembly, 1500 RPM and 3-5 users, used on the G3-050, G6-050 Smart G-Vacuums.
• 00841709121395 - Midmark: 2024-04-30 Smart G-Vacuum Base unit assembly, 1725 RPM and 5-7 users, used on the G5-010, G10-050 Smart G-Vacuums.