NIM-Pulse®

GUDID 00643169782457

PATIENT INTFC 8253210 NIM PULSE 3.0 ROHS

MEDTRONIC XOMED, INC.

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• Primary Device ID: 00643169782457
• NIH Device Record Key: bb4aa0b3-8d4e-4822-b137-370b01be388e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIM-Pulse®
• Version Model Number: 8253210
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169782457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083124

FDA Product Code

• GWF: STIMULATOR, ELECTRICAL, EVOKED RESPONSE

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: 2018-07-06
• Device Publish Date: 2017-02-10

On-Brand Devices [NIM-Pulse®]

• 00613994529060: MAINFRAME 8253202 NIM PULSE 3.0 INTL
• 00643169782457: PATIENT INTFC 8253210 NIM PULSE 3.0 ROHS
• 00643169283282: PATIENT INTFC 8253210 NIM PULSE 3.0 ROHS
• 00643169230415: MAINFRAME 8253202 NIMPULSE 3.0 INTL ROHS