AccessGUDID - DEVICE: CT Exprès™ - Day Set III HP (17630039300026)

GUDID

Device Identifier (DI) Information

Brand Name: CT Exprès™ - Day Set III HP
Version or Model: 640460
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 640460
Company Name: Bracco Injeneering SA

Primary DI Number: 17630039300026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482489007 *Terms of Use

Device Description: No description.

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?
47259	Contrast medium injection system syringe	A component of a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is primarily an exchangeable plunger-in-barrel chamber for the medium/solution; the movement of the plunger (piston) is controlled by the contrast medium/solution injector. It is typically made of plastic materials and can be reused for several patients, e.g., up to five patients. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZQ	Injector, Contrast Medium, Automatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151048	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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 10 and 35 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ecd7f5f-7786-4722-ad5b-5e8e62b5cee2
Public Version Date: April 20, 2020
Public Version Number: 4
DI Record Publish Date: September 20, 2016