AccessGUDID - DEVICE: Invivo (00884838081758)

GUDID

Device Identifier (DI) Information

Brand Name: Invivo
Version or Model: 4535-303-46291
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 453530346291
Company Name: Philips DS North America LLC

Primary DI Number: 00884838081758
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 118983916 *Terms of Use

Device Description: SensaVue Cart Assembly

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, nuclear magnetic resonance imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 92648912-328b-4a29-b3dc-aa3034113b28
Public Version Date: August 10, 2023
Public Version Number: 5
DI Record Publish Date: April 17, 2020