AccessGUDID - DEVICE: EmpowerCTA®+ Injector System with EDA (47630039300812)

GUDID

Device Identifier (DI) Information

Brand Name: EmpowerCTA®+ Injector System with EDA
Version or Model: 017383
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 017383
Company Name: Bracco Injeneering SA

Primary DI Number: 47630039300812
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 482489007 *Terms of Use
Previous DI: 47630039300447

Device Description: Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630039300426 1 x EmpowerSync® Power Supply GTIN : 37630039300839 1 x Injector GTIN : 37630039300822

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
57999	CT contrast medium injection system, line-powered, mobile	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 (e.g., syringe piston drivers, tubing roller pumps) capable of delivering media with the pressure, flow range, and volume required for CT studies, and is mobile (e.g., on a wheeled pedestal). 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
DSB	Plethysmograph, Impedance
JAK	System, X-Ray, Tomography, Computed

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d97ebe67-cf7e-4e0a-bb9f-e7e440aabaeb
Public Version Date: May 30, 2024
Public Version Number: 3
DI Record Publish Date: October 26, 2017