MIDMARK IQHOLTER® PLUG-IN SOFTWARE

GUDID 00841709118067

IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.

MIDMARK CORPORATION

Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser

• Primary Device ID: 00841709118067
• NIH Device Record Key: 9d427d3b-c0da-432d-8d9a-227401abe465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDMARK IQHOLTER® PLUG-IN SOFTWARE
• Version Model Number: P/N 4-100-3140
• 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: false
• 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: false

Customer Support Contacts

• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com
• Phone: 18006436275
• Email: support@midmark.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841709118067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031466

FDA Product Code

• MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-05
• Device Publish Date: 2020-12-28

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.