AccessGUDID - DEVICE: EmpowerCTA+ Injector System (47630039302014)

GUDID

Device Identifier (DI) Information

Brand Name: EmpowerCTA+ Injector System
Version or Model: 017285, 019775
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bracco Injeneering SA

Primary DI Number: 47630039302014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482489007 *Terms of Use

Device Description: Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
JAK	System, X-Ray, Tomography, Computed
DSB	Plethysmograph, Impedance
IZQ	Injector, Contrast Medium, Automatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071378	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1af6e219-44f2-4b0c-90b0-87e8c49ce884
Public Version Date: September 02, 2024
Public Version Number: 2
DI Record Publish Date: October 17, 2023