Electrocardiograph

GUDID 06944413812857

Edan Instruments, Inc.

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• Primary Device ID: 06944413812857
• NIH Device Record Key: 9b16ec13-c38e-4068-8bdf-d1089e58a2a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrocardiograph
• Version Model Number: SE-1202
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413812857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210140

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: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [Electrocardiograph]

• 06944413808980: SL18A
• 06944413808966: SL12A
• 06944413807921: ECG-3F Plus
• 06944413807792: ECG-1201
• 06944413807761: ECG-1200
• 06944413807754: ECG-1200 Plus
• 06944413807747: ECG-12 B
• 06944413806979: ECG-3F
• 06944413806962: ECG-3
• 06944413806955: ECG-3 Plus
• 06944413806931: ECG-12C
• 06944413806924: ECG-12
• 06944413806917: ECG-12 Plus
• 06944413806900: ECG-6 Pro
• 06944413806894: ECG-6 Plus
• 06944413806887: ECG-6
• 06944413806870: SL6A
• 06944413802520: SE-301
• 06944413802216: SE-18
• 06944413801554: SE-1201
• 06944413800724: SE-601C
• 06944413800717: SE-601B
• 06944413800700: SE-601A
• 06944413800380: SE-1200 Express
• 06944413800373: SE-1200
• 06944413800366: SE-12 Express
• 06944413800359: SE-12
• 06944413800342: SE-600
• 06944413800335: SE-6
• 06944413800328: SE-300B
• 06944413800311: SE-300A
• 06944413800304: SE-3
• 06944413800298: SE-3
• 06944413812857: SE-1202
• 06944413820616: SE-1200Pro
• 06944413820562: SE-1201Pro