AccessGUDID - DEVICE: CAREMIBRAIN (08437018413188)

GUDID

Device Identifier (DI) Information

Brand Name: CAREMIBRAIN
Version or Model: FP-0600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP-0600
Company Name: GENERAL EQUIPMENT FOR MEDICAL IMAGING SA

Primary DI Number: 08437018413188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 463337670 *Terms of Use

Device Description: CareMiBrain is a Positron Emission Tomography system for brain imaging in neurological and oncological applications. It has two main parts: the detection and acquisition system and the Control Unit.

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:	Yes
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?
60644	Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232569	000

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
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 1776 Millimeter
Weight: 300 Kilogram
Width: 780 Millimeter
Depth: 203 Millimeter
Length: 2281 Millimeter

Device Record Status

Public Device Record Key: 9a25f03f-8d9b-446f-a390-e3c0ba7bc288
Public Version Date: June 05, 2024
Public Version Number: 1
DI Record Publish Date: May 28, 2024