EKG Patch (Pediatric 1) PA010PO10213C

GUDID 00860007764462

Electrocardiograph Electrode Patch (Pediatric 1)

Mg Medical Products LLC

Ambulatory recorder conductive patch

• Primary Device ID: 00860007764462
• NIH Device Record Key: 335a66ab-b857-4623-920d-5b5e6f8fb496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EKG Patch (Pediatric 1)
• Version Model Number: 1
• Catalog Number: PA010PO10213C
• Company DUNS: 094834451
• Company Name: Mg Medical Products LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007764462 [Primary]

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-05
• Device Publish Date: 2025-02-25

Devices Manufactured by Mg Medical Products LLC

• 00860007764431 - EKG Patch (Pediatric 4): 2025-03-05 Electrocardiograph Electrode Patch (Pediatric 4)
• 00860007764448 - EKG Patch (Pediatric 3): 2025-03-05 Electrocardiograph Electrode Patch (Pediatric 3)
• 00860007764455 - EKG Patch (Pediatric 2): 2025-03-05 Electrocardiograph Electrode Patch (Pediatric 2)
• 00860007764462 - EKG Patch (Pediatric 1): 2025-03-05Electrocardiograph Electrode Patch (Pediatric 1)
• 00860007764462 - EKG Patch (Pediatric 1): 2025-03-05 Electrocardiograph Electrode Patch (Pediatric 1)
• 00860007764424 - EKG Patch Solution: 2025-01-17 Portable, 12-lead ECG testing kit.
• 00198715993158 - EKG Patch Solution: 2024-12-27 Portable, 12-lead ECG testing kit.
• 00860007764400 - EKG Patch (Medium): 2021-11-02 Electrocardiograph Electrode Patch (Adult Medium)
• 00860007764417 - EKG Patch (Large): 2021-11-02 Electrocardiograph Electrode Patch (Adult Large)