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

• 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

• 10812594013239 - NeoSnug Micro: 2024-10-22 NeoSnug is intended to support, secure, and hold gastrointestinal tubes on patients’ skin. 30 per box - 15 sets of 2 (left & R
• 10812594013246 - NeoSnug Oral - Small: 2024-10-22 NeoSnug is intended to support, secure, and hold gastrointestinal tubes on patients’ skin. 40 pieces
• 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)