GUDID 00887517163233

NVM5 EMG ET Tube, 8mm ENT Kit

Nuvasive, Inc.

Neurophysiologic monitoring system

• Primary Device ID: 00887517163233
• NIH Device Record Key: d1b0a8df-c8f4-4172-9f6e-82fa59593772
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2010480
• 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	00887517163233 [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.

• 00195377161307 - ReLine: 2024-05-29 RELINE Reducer, Politician
• 00195377161314 - ReLine: 2024-05-29 RELINE Lock Screw Starter, Politician
• 00195377055521 - Nimbus: 2024-05-01 Maxcess Adapter, A-Arm Threaded
• 00195377055538 - Nimbus: 2024-05-01 Nimbus Adapter, Large Clamp
• 00195377055545 - Nimbus: 2024-05-01 Nimbus Adapter, Medium Clamp
• 00195377055552 - Nimbus: 2024-05-01 Nimbus Adapter, Small Clamp
• 00195377061232 - Nimbus: 2024-05-01 Nimbus Adapters Tray
• 00195377159847 - XLIF: 2024-05-01 XLIF Prone Anchor and Shim, Fixation Lt