NeoLead® N301CE

GUDID 00812594012082

NeoLead is a set of three/five ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph electrode (per FDA regulation# 870.2360 ) is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Neotech Products LLC

Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode

• Primary Device ID: 00812594012082
• NIH Device Record Key: 7b45614b-08c9-4001-9009-e869c8ed8c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoLead®
• Version Model Number: Standard CE
• Catalog Number: N301CE
• Company DUNS: 198013435
• Company Name: Neotech Products LLC
• Device Count: 20
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812594012082 [Unit of Use]
GS1	10812594012089 [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: 2023-11-07
• Device Publish Date: 2023-10-30

Devices Manufactured by Neotech Products LLC

• 00812594012082 - NeoLead®: 2023-11-07NeoLead is a set of three/five ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph electrode (per FDA regulation# 870.2360 ) is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
• 00812594012082 - NeoLead®: 2023-11-07 NeoLead is a set of three/five ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph elec
• 00812594011467 - EZ Care Softouch Large - Black: 2023-09-18 Trach Holder 18" - Tan
• 10812594012928 - NeoSnug: 2023-09-18 Tubing Holder - Unique shape ideal for securing tubes close to the nares - 15 sets of 2 (Left/Right)
• 00812594013430 - NeoSmile Hydrogel: 2023-09-15 Hydrogel Temp Probe 75pcs / Box
• 00812594013478 - Neotech Bridge - Kit: 2023-06-14 Breastfeeding Assistance Device - Kit
• 00812594012600 - Neotech Bridge (30 pcs): 2023-06-14 Breastfeeding Assistance Device (30 pcs per Box)
• 10812594010245 - Meconium Aspirator: 2022-07-26
• 10812594010313 - Suction Caddy (N245): 2022-07-26 Suction Device Holder