Abyssal

GUDID 04947507000200

ABYSSAL, K.K.

Electrocardiography telemetric 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