AccessGUDID - DEVICE: EmpowerCTA®+ Injector System (47630039300904)

GUDID

Device Identifier (DI) Information

Brand Name: EmpowerCTA®+ Injector System
Version or Model: 017285
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 017285
Company Name: Bracco Injeneering SA

Primary DI Number: 47630039300904
Issuing Agency: GS1
Commercial Distribution End Date: July 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 482489007 *Terms of Use
Previous DI: 47630039300782

Device Description: Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 37630039300471 1 x EmpowerSync® Power Supply GTIN : 37630039300839 1 x Injector GTIN : 37630039300891

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?
58000	CT contrast medium injection system, line-powered, stationary	An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for CT studies, and is stationary (e.g., fixed to a room rack). The system may synchronize media delivery with the x-ray generator during CT scanning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZQ	Injector, Contrast Medium, Automatic
JAK	System, X-Ray, Tomography, Computed
DSB	Plethysmograph, Impedance

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
Handling Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -29 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 10 and 110 KiloPascal
Special Storage Condition, Specify: Dry environment

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 856fc2a0-4db5-4781-ba7b-8e88f4367dff
Public Version Date: April 09, 2024
Public Version Number: 3
DI Record Publish Date: July 06, 2018