ECG Patient Cable

GUDID 00816396022294

ECG Patient Cable, Shielded, 3 Lead, AHA-IEC, 1.5M

IVY BIOMEDICAL SYSTEMS, INC.

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• Primary Device ID: 00816396022294
• NIH Device Record Key: 50008009-d0b7-42a6-a727-33a0222c92bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Patient Cable
• Version Model Number: 590475
• Company DUNS: 109132019
• Company Name: IVY BIOMEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396022294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942321

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-31

On-Brand Devices [ECG Patient Cable]

• 00816396022294: ECG Patient Cable, Shielded, 3 Lead, AHA-IEC, 1.5M
• 00816396021716: ECG Patient Cable, Shielded, 4-Lead, IEC, 10 ft
• 00816396021679: ECG Patient Cable, Shielded, 4-Lead, AHA, 10 ft
• 00816396021631: ECG Patient Cable, Shielded, 3-Lead, AHA, 40 in
• 00816396021617: ECG Patient Cable, Shielded, 3-Lead, IEC, 40 in
• 00816396021594: ECG Patient Cable, Shielded, 3-Lead, IEC, 10 ft
• 00816396021570: ECG Patient Cable, Shielded, 3-Lead, AHA, 10 ft
• 00816396022829: ECG Trunk Cable, Shielded, 3 Lead, AHA/IEC, 40 in
• 00816396022713: ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 10 ft
• 00816396022706: ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 5 ft
• 00816396022577: ECG Trunk Cable MRI, 4 Lead, Single pin, 40 in, AHA/IEC
• 00816396022560: ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 40 in
• 00816396022553: ECG Trunk Cable MRI, 4 Lead, Single pin, 40 in