NeoLead 5-UP CE N315B CE

GUDID 00812594011825

NEOTECH PRODUCTS, INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 00812594011825
• NIH Device Record Key: 358fe1fe-0032-47a7-8d6f-85bdd8f155d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoLead 5-UP CE
• Version Model Number: 8012594011825
• Catalog Number: N315B CE
• Company DUNS: 198013435
• Company Name: NEOTECH PRODUCTS, INC.
• 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: true
• 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	00812594011825 [Primary]

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: 2018-03-29
• Device Publish Date: 2016-09-14

On-Brand Devices [NeoLead 5-UP CE]

• 00812594011825: 8012594011825
• 10812594011822: Electrode (Box of 20)