NeoLead N301B

GUDID 00812594011054

NEOTECH PRODUCTS, INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 00812594011054
• NIH Device Record Key: d0127057-ae49-4858-8a3f-b9d17b8fa919
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoLead
• Version Model Number: 812594011054
• Catalog Number: N301B
• 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	00812594011054 [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]

• 00812594011054: 812594011054
• 10812594011051: Electrode (Box of 20)