Eclipse Mini 98900-L

GUDID 10841522129209

ECLIPSE MINI RECORDER, MULTILINGUAL,LOAN

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiographic ambulatory recorder

• Primary Device ID: 10841522129209
• NIH Device Record Key: ecea8baa-b173-4cf7-9026-432ea5030d39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse Mini
• Version Model Number: Eclipse Mini
• Catalog Number: 98900-L
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522129209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212317

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: 2024-03-27
• Device Publish Date: 2024-03-19

On-Brand Devices [Eclipse Mini]

• 10841522128769: ECLIPSE MINI RECORDER, MULTILINGUAL
• 10841522129209: ECLIPSE MINI RECORDER, MULTILINGUAL,LOAN
• 10841522130762: ECLIPSE MINI ECG SENSOR, DEFIB SAFE
• 10841522130755: ECLIPSE MINI ECG SENSORS, DEFIB SAFE (BOX OF 10)