Abyssal

GUDID 04947507000200

ABYSSAL, K.K.

Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography telemetric monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver

• Primary Device ID: 04947507000200
• NIH Device Record Key: dc713abf-48a2-4104-ab0c-688e35230c17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abyssal
• Version Model Number: NA-6141D
• Company DUNS: 692886864
• Company Name: ABYSSAL, K.K.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04947507000200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020084

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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: 2022-11-18
• Device Publish Date: 2022-11-10

On-Brand Devices [Abyssal]

• 04947507000163: NP-6030
• 04947507000200: NA-6141D
• 04947507000194: NA-6141C
• 04947507000095: NP-1430
• 04947507000040: NA-6141A