AccessGUDID - DEVICE: Xenon Master (00850022357848)

GUDID

Device Identifier (DI) Information

Brand Name: Xenon Master
Version or Model: MN0409
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medi/Nuclear Corporation, Inc.

Primary DI Number: 00850022357848
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079628327 *Terms of Use

Device Description: Xenon Administration Set: 1 EA MN0309: Face Mask, Air-Cushioned, Adult Size 5, with Injection Port & Bacteria Filter, Flexible Tubing. 1 EA MN2772: Moisture Absorbing Granule Cartridge, Disposable,(Drierite). 1 EA MN2773: C02 Absorbing Granule Cartridge, Disposable, (Soda Lime).

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:	Yes
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
CBL	Absorbent, Carbon-Dioxide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 1bc6fcc5-f5fd-4584-840a-c1c032675131
Public Version Date: September 18, 2024
Public Version Number: 1
DI Record Publish Date: September 10, 2024