EKG Glove

GUDID 00862795000401

EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, collect data for an EKG - Medium size

Ineedmd Holdings, Inc.

Electrocardiographic electrode, single-use

• Primary Device ID: 00862795000401
• NIH Device Record Key: 38c9d8ac-9566-4eca-8b72-083c1ffd45d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EKG Glove
• Version Model Number: Medium Size
• Company DUNS: 079403749
• Company Name: Ineedmd Holdings, 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00862795000401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033559

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: 2017-07-03

On-Brand Devices [EKG Glove]

• 00862795000418: EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, collec
• 00862795000401: EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, collec