Invivo

Basic Information

• Brand Name: Invivo
• Primary DI: 00884838081758
• Version / Model: 4535-303-46291
• Catalog Number: 453530346291
• Company Name: Philips DS North America LLC
• Labeler DUNS: 118983916
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-17
• Public Version: 5
• Public Version Date: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: 92648912-328b-4a29-b3dc-aa3034113b28
• Distribution End Date: 2021-08-31

Device Description

SensaVue Cart Assembly

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNH	System, nuclear magnetic resonance imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40940	MRI system workstation	A freestanding image processing workstation specifically designed to be networked with one or more magnetic resonance imaging (MRI) systems. An MRI workstation differs from the operator's console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the MRI system's operator console. It is configured to provide the capability to further process, manipulate and/or view patient images and information collected from one or more MRI systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838081758	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius