DR200 NEMK129

GUDID M581NEMK1290

DR200 holter recorder w/ 3L patient cable

Northeast Monitoring, Inc.

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 Electrocardiographic long-term ambulatory recording analyser

• Primary Device ID: M581NEMK1290
• NIH Device Record Key: a8499ced-5aef-4b3e-85e1-b4ecd0ad0413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DR200
• Version Model Number: DR200 3L
• Catalog Number: NEMK129
• Company DUNS: 837441815
• Company Name: Northeast Monitoring, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram
• Length: 8.6 Centimeter
• Width: 6 Centimeter
• Depth: 1.2 Centimeter
• Weight: 70.9 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C
• Special Storage Condition, Specify: Between 0 and 0 *allowed storage conditions: -40C to 70C

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M581NEMK1290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061293

FDA Product Code

• MWJ: Electrocardiograph, Ambulatory (Without Analysis)

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: 2021-11-04
• Device Publish Date: 2021-10-27

On-Brand Devices [DR200]

• M581NEMK960: DR200 holter recorder w/ 7L patient cable
• M581NEMK950: DR200 holter recorder w/ 5L patient cable
• M581NEMK940: DR200 holter recorder w/ 2L patient cable
• M581NEMK1290: DR200 holter recorder w/ 3L patient cable