GUDID 00887517163219

NVM5 EMG ET Tube, 6mm ENT Kit

Nuvasive, Inc.

Neurophysiologic monitoring system

• Primary Device ID: 00887517163219
• NIH Device Record Key: 9c69d48c-c519-4eea-903a-91020c4e9ac9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2010460
• Company DUNS: 053950783
• Company Name: Nuvasive, 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517163219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133530

FDA Product Code

• BTR: Tube, tracheal (w/wo connector)

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: 2019-11-20
• Device Publish Date: 2019-11-12

Devices Manufactured by Nuvasive, Inc.

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• 00887517063052 - SpheRx: 2024-04-15 SpheRx PPS Counter Torque, Reduction
• 00887517065216 - Precept: 2024-04-15 PRECEPT Handle, Fascial Splitting
• 00887517075376 - NVJJB: 2024-04-15 NVJJB EMG Harness Extensions
• 00887517078568 - PCM: 2024-04-15 PCM Slap Hammer
• 00887517084187 - VuePoint: 2024-04-15 VuePoint II Handle, Universal
• 00887517084644 - VuePoint: 2024-04-15 VP II Handle, Torque Final Tightening
• 00887517084675 - VuePoint: 2024-04-15 VP II Handle, Torque Rod-Rod Driver