Nalu Medical 71003

GUDID 00812537037332

Nalu IPG Kit (Ported, Single 8)

NALU MEDICAL, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 00812537037332
• NIH Device Record Key: a74d6fd4-69af-4e71-adb0-8114f08ad6ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nalu Medical
• Version Model Number: 71003
• Catalog Number: 71003
• Company DUNS: 067140761
• Company Name: NALU MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812537037332 [Primary]

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-09
• Device Publish Date: 2024-05-01

Devices Manufactured by NALU MEDICAL, INC.

• 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)
• 00812537037219 - Nalu Medical, Inc.: 2024-05-09 Lead Kit (8 contact, 60 cm)
• 00812537037226 - Nalu Medical, Inc.: 2024-05-09 Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
• 00812537037233 - Nalu Medical, Inc.: 2024-05-09 Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
• 00812537037332 - Nalu Medical: 2024-05-09Nalu IPG Kit (Ported, Single 8)
• 00812537037332 - Nalu Medical: 2024-05-09 Nalu IPG Kit (Ported, Single 8)
• 00812537037349 - Nalu Medical, Inc.: 2024-05-09 Nalu IPG Kit (Ported, Dual 8)