ECG Snap Electrodes

GUDID 00616784710136

DYNAREX CORPORATION

Electrocardiographic electrode, single-use

• Primary Device ID: 00616784710136
• NIH Device Record Key: 3d85b567-227f-463d-a7cb-a7ca531b2699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Snap Electrodes
• Version Model Number: 7101
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 3
• 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: true
• 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	00616784710112 [Unit of Use]
GS1	00616784710129 [Primary]
GS1	00616784710136 [Package]; Contains: 00616784710129; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093327

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: 2016-09-24

On-Brand Devices [ECG Snap Electrodes]

• 00616784710334: 7103
• 00616784710235: 7102
• 00616784710136: 7101