AccessGUDID - DEVICE: SONIC SHOT GX (04560138480700)

GUDID

Device Identifier (DI) Information

Brand Name: SONIC SHOT GX
Version or Model: 070
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEMOTO KYORINDO CO.,LTD.

Primary DI Number: 04560138480700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 692691710 *Terms of Use

Device Description: Nemoto SONIC SHOT GX contrast delivery system for MRI applications.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
58001	MRI 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 magnetic resonance imaging (MRI) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using MRI). 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 MRI studies, and is mobile. It may interface with the MRI system or a monitoring device to control timing of contrast injections; it is made entirely of non-ferromagnetically active materials for MRI compatiblity.	Active	false

FDA Product Code

[?]

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

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
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94cc4ddd-481a-445c-a271-b3cb061ae886
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 15, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
14560138480707	1	04560138480700		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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