KIT,SAMPLE,AGENTS,3160 989803152661

GUDID 00884838045088

INVIVO CORPORATION

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• Primary Device ID: 00884838045088
• NIH Device Record Key: 71a79b61-d78d-44ef-a83e-0c87968dbdc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT,SAMPLE,AGENTS,3160
• Version Model Number: 989803152661
• Catalog Number: 989803152661
• Company DUNS: 013649151
• Company Name: INVIVO CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838045088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090785

FDA Product Code

• MWI: MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

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: 2016-11-16

On-Brand Devices [KIT,SAMPLE,AGENTS,3160]

• 00884838045088: 989803152661
• 00884838107304: 989803152661