ECG Lead Wires 590435

GUDID 00816396021792

ECG Lead Wires, Radiotranslucent, 4 Lead Set, AHA, 30 in

IVY BIOMEDICAL SYSTEMS, INC.

Radiolucent electrocardiographic lead

• Primary Device ID: 00816396021792
• NIH Device Record Key: 4cdac1b2-57fd-41ac-893f-768895846729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Lead Wires
• Version Model Number: 590435
• Catalog Number: 590435
• Company DUNS: 109132019
• Company Name: IVY BIOMEDICAL SYSTEMS, INC.
• 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

Customer Support Contacts

• Phone: 203-481-4183
• Email: sales@ivybiomedical.com
• Phone: 203-481-4183
• Email: sales@ivybiomedical.com
• Phone: 203-481-4183
• Email: sales@ivybiomedical.com

Device Dimensions

• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396021792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970755

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [ECG Lead Wires]

• 00816396022478: ECG Lead Wires, Radiotranslucent, 3 Lead Set, IEC, 36 in
• 00816396022348: ECG Lead Wires, Radiotranslucent, 3 Lead Set, AHA, 36 in
• 00816396021877: ECG Lead Wires, Radiotranslucent, 3 Lead Set, IEC, 30 in
• 00816396021860: ECG Lead Wires, Radiotranslucent, 3 Lead Set, IEC, 24 in
• 00816396021853: ECG Lead Wires, Radiotranslucent, 3 Lead Set, AHA, 30 in
• 00816396021846: ECG Lead Wires, Radiotranslucent, 3 Lead Set, AHA, 24 in
• 00816396021839: ECG Lead Wires, Radiotranslucent, 4 Lead Set, IEC, 36 in
• 00816396021822: ECG Lead Wires, Radiotranslucent, 4 Lead Set, IEC, 30 in
• 00816396021808: ECG Lead Wires, Radiotranslucent, 4 Lead Set, AHA, 36 in
• 00816396021792: ECG Lead Wires, Radiotranslucent, 4 Lead Set, AHA, 30 in
• 00816396021778: ECG Lead Wires, Radiotranslucent, 3 Lead Set, IEC, 40 in
• 00816396021761: ECG Lead Wires, Radiotranslucent, 3 Lead Set, AHA, 40 in
• 00816396021754: ECG Lead Wires, Metallic, 3 Lead Set, IEC, 30 in
• 00816396021747: ECG Lead Wires, Metallic, 4 Lead Set, IEC, 36 in
• 00816396021730: ECG Lead Wires, Metallic, 4 Lead Set, IEC, 30 in
• 00816396021723: ECG Lead Wires, Metallic, 4 Lead Set, IEC, 24 in
• 00816396021709: ECG Lead Wires, Metallic, 4 Lead Set, AHA, 36 in
• 00816396021693: ECG Lead Wires, Metallic, 4 Lead Set, AHA, 30 in
• 00816396021686: ECG Lead Wires, Metallic, 4 Lead Set, AHA, 24 in
• 00816396021662: ECG Lead Wires, Metallic, 3 Lead Set, AHA, 30 in
• 00816396021648: ECG Lead Wires, Metallic, 3 Lead Set, AHA, 40 in
• 00816396021624: ECG Lead Wires, Metallic, 3 Lead Set, IEC, 40 in
• 00816396021600: ECG Lead Wires, Metallic, 3 Lead Set, IEC, 24 in
• 00816396021587: ECG Lead Wires, Metallic, 3 Lead Set, AHA, 24 in
• 00816396022850: ECG Lead Wires, Metallic, 3 Lead Set,AHA, 36 in
• 00816396022843: ECG Lead Wires, Metallic, 3 Lead Set, IEC, 36 in
• 00816396022836: ECG Lead Wires, Shielded, 3 Lead AHA/IEC, 5ft