NeoLead RadioLucent CE N305CE

GUDID 10812594011808

Electrode (Box of 20)

NEOTECH PRODUCTS, INC.

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use 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 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: 10812594011808
• NIH Device Record Key: caf8948f-79c0-414e-bb74-6c815cdf5cf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoLead RadioLucent CE
• Version Model Number: 10812594011808
• Catalog Number: N305CE
• 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	00812594011801 [Unit of Use]
GS1	10812594011808 [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: 2017-02-20

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