Neolead 5-UP N315

GUDID 10812594011228

Electrode (Box of 20)

NEOTECH PRODUCTS, INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 10812594011228
• NIH Device Record Key: 54a919e3-8303-4d75-aa92-dec02bd8e96a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neolead 5-UP
• Version Model Number: 10812594011228
• Catalog Number: N315
• Company DUNS: 198013435
• Company Name: NEOTECH PRODUCTS, INC.
• 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	00812594011221 [Unit of Use]
GS1	10812594011228 [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: 3
• Public Version Date: 2021-06-14
• Device Publish Date: 2017-02-21

Devices Manufactured by NEOTECH PRODUCTS, INC.

• 00812594011405 - Little Sucker Cover: 2022-05-31 Protective Cover (Qty. 50)
• 10812594010795 - Meconium Aspirator: 2022-01-24
• 10812594010818 - Meconium Aspirator Tinted: 2022-01-24
• 10812594012584 - NeoBond Shapes (Hearts) (N7426): 2022-01-24
• 00812594010330 - NeoBond: 2021-06-23 Hydrocolloid Strip
• 00812594011603 - NeoBond: 2021-06-23 Hydrocolloid Roll - 1" x 15' Roll
• 00812594012198 - EZCare Softouch - Pink: 2021-06-23 Trach Holder 6" - Pink
• 00812594012204 - EZCare Softouch - Pink: 2021-06-23 Trach Holder 7" - Pink