TD2 Therapy Disc 34014-001

GUDID 00812537037134

TD2 Therapy Disc a-la-carte

NALU MEDICAL, INC.

Implantable spinal cord electrical stimulation system programmer

• Primary Device ID: 00812537037134
• NIH Device Record Key: 9ce10a31-81e6-4dca-aedd-b4ebd414b68e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TD2 Therapy Disc
• Version Model Number: 34014-001
• Catalog Number: 34014-001
• Company DUNS: 067140761
• Company Name: NALU MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812537037134 [Primary]

FDA Product Code

• GZF: Stimulator, Peripheral Nerve, Implanted (Pain Relief)

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: 2026-01-27
• Device Publish Date: 2026-01-19

Devices Manufactured by NALU MEDICAL, INC.

• 00812537030234 - Therapy Disc: 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu
• 00812537032399 - Therapy Disc: 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu
• 00812537035802 - Therapy Disc, Reduced Warranty: 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu
• 00812537037134 - TD2 Therapy Disc: 2026-01-27TD2 Therapy Disc a-la-carte
• 00812537037134 - TD2 Therapy Disc: 2026-01-27 TD2 Therapy Disc a-la-carte
• 00812537037660 - Nalu Medical, Inc.: 2025-12-16 Trial Lead Kit (8 contact, 40 cm)
• 00812537037189 - Nalu Medical, Inc.: 2024-05-09 Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm)
• 00812537037196 - Nalu Medical, Inc.: 2024-05-09 Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm)
• 00812537037202 - Nalu Medical, Inc.: 2024-05-09 Lead Kit (8 contact, 40 cm)