CardioTouch3000

GUDID 18809276943542

System, ecg analysis

Bionet CO,LTD

ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor ST-segment electrocardiographic monitor

• Primary Device ID: 18809276943542
• NIH Device Record Key: d5c17a4e-6805-4f61-bc88-47554ee071a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioTouch3000
• Version Model Number: CardioTouch3000
• Company DUNS: 689708212
• Company Name: Bionet CO,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809276943545 [Primary]
GS1	18809276943542 [Package]; Contains: 08809276943545; Package: Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023034

FDA Product Code

• DPS: Electrocardiograph

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: 2021-07-23
• Device Publish Date: 2021-07-15

Devices Manufactured by Bionet CO,LTD

• 18809276940282 - CardioXP: 2021-07-23 ELECTROCARDIOGRAPH
• 18809276943535 - CardioCare2000: 2021-07-23 System, ecg analysis
• 18809276943542 - CardioTouch3000: 2021-07-23System, ecg analysis
• 18809276943542 - CardioTouch3000: 2021-07-23 System, ecg analysis
• 18809276943559 - Cardio7: 2021-07-23 ELECTROCARDIOGRAPH
• 18809276943597 - FC700: 2021-07-23 SYSTEM, MONITORING, PERINATAL
• 18809276943603 - FC1400: 2021-07-23 SYSTEM, MONITORING, PERINATAL
• 18809276943641 - BM3/BM3 Plus: 2021-07-23 MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• 18809276943726 - Spiro Handle: 2021-07-23 SPIROMETER, DIAGNOSTIC