AccessGUDID - DEVICE: Xenon Master (00857863007390)

GUDID

Device Identifier (DI) Information

Brand Name: Xenon Master
Version or Model: XE-102
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medi/Nuclear Corporation, Inc.

Primary DI Number: 00857863007390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079628327 *Terms of Use

Device Description: Xenon/Master Patient Delivery System. (For Xenon Gas Delivery). Mobile Cabinet type constructed of wood and almond color formica with leaded areas for Xenon Delivery. Includes one charcoal activated trap and has extra space for one additional activated trap (optional) for high use facilities, swivel casters with front brakes. Xenon accessory samples included.

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?
40907	Xenon administration system, diagnostic x-ray/CT	An assembly of devices which is a component of an x-ray/CT (computed tomography) system used in diagnostic x-ray applications for the delivery (by inhalation or injection) of xenon gas during real-time imaging studies of blood flow or other physical or physiological parameters. It can be a simple canister system with associated tubing, mask or mouthpiece, or be composed of an electrically or software-controlled operator's console that includes, e.g., software, injector system, physiological gating devices, gas canister holder(s), gas mixers, tubing sets, gas traps, filters, alarms, mask or mouthpieces.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYT	System, Rebreathing, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K810819	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
Special Storage Condition, Specify: store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Weight: 200 Pound
Height: 42 Inch
Length: 18 Inch
Width: 18 Inch

Device Record Status

Public Device Record Key: 08f0a865-788a-4fba-89fe-b368461e852a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 09, 2017