AccessGUDID - DEVICE: Ingenia MR-OR (00884838112766)

GUDID

Device Identifier (DI) Information

Brand Name: Ingenia MR-OR
Version or Model: Flextrak OR Ingenia 1.5T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 781437
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838112766
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
46148	Patient transfer system, manual	A wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance (i.e., without changing horizontal body position, lifting, rolling, or dragging). The device typically includes a patient-transfer mechanism (e.g., mechanical, hydraulic) easy to operate by an attendant with minimal physical effort. It is used in hospitals and other healthcare facilities to reduce injuries to both patients and staff while transferring non-ambulatory, comatose, or neurologically-injured patients between beds, tables, and/or stretchers.	Obsolete	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 -20 and 50 Degrees Celsius
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1bee3d7f-a771-4747-8d63-e4701597b212
Public Version Date: September 26, 2023
Public Version Number: 2
DI Record Publish Date: September 01, 2022