Vyaire

GUDID 28809083941394

Pediatric Resting ECG Electrodes, Mild Adhesive

Sunmed Group Holdings, LLC

Electrocardiographic electrode, single-use

• Primary Device ID: 28809083941394
• NIH Device Record Key: 2d51f79d-6fdf-4395-b039-d83b5c896c79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vyaire
• Version Model Number: 2009101-103P
• Company DUNS: 119058668
• Company Name: Sunmed Group Holdings, LLC
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809083941390 [Primary]
GS1	18809083941397 [Package]; Contains: 08809083941390; Package: Inner Box [10 Units]; In Commercial Distribution
GS1	28809083941394 [Package]; Contains: 18809083941397; Package: Carton Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040784

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: 2
• Public Version Date: 2024-12-11
• Device Publish Date: 2018-11-15

On-Brand Devices [Vyaire]

• 18809083941687: ELECTRODE, ADULT, FOAM, ROUND, RADIOLUCENT, SOLID GEL, 50/POUCH
• 18809083941663: ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID GEL, 50/POUCH
• 18809083941649: ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID GEL, 5/STRIP
• 18809083941601: ELECTRODE, PEDIATRIC, CLOTH, ROUND, SOLID GEL, 50/POUCH
• 18809083941588: ELECTRODE, ADULT, CLOTH, ROUND, SOLID GEL, 50/POUCH
• 18809083941564: ELECTRODE, ADULT, FOAM, ROUND, WET GEL, 50/POUCH
• 18809083941540: ELECTRODE, PEDIATRIC, FOAM, ROUND, SOLID GEL, 50/POUCH
• 18809083941526: ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 50/POUCH
• 18809083941502: ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 5/STRIP
• 18809083941489: ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 3/STRIP
• 18809083941465: Radiolucent Neonatal Cloth Monitoring Snap Electrodes
• 18809083941441: Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Lead wires (IEC version colors le
• 18809083941427: Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Ldwrs
• 28809083941394: Pediatric Resting ECG Electrodes, Mild Adhesive
• 28809083941363: Adult Resting ECG Electrodes, Moderate Adhesive
• 28809083941332: Adult Resting ECG Electrodes, Aggressive Adhesive
• 28809083941301: Adult Resting ECG Electrodes, Moderate Adhesive