AccessGUDID - DEVICE: Xenon Master Administration Set (00857863007932)

GUDID

Device Identifier (DI) Information

Brand Name: Xenon Master Administration Set
Version or Model: AV-100-XBU
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medi/Nuclear Corporation, Inc.

Primary DI Number: 00857863007932
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079628327 *Terms of Use

Device Description: Xenon Back-Up System, Complete Aero/Vent Jr. Radioaerosol Delivery System with 1 lead shield, 4 radioaerosol kits, 1 rigid mouthpiece, 2 air cushioned mask and 2 safe-t-shield mouthpieces

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
16784	Radioaerosol administration set	A collection of devices used to quickly deliver radioaerosol to a patient for ventilatory pulmonary scintigraphy. It is used with an aerosol pump/nebulizer or a compressed air line to generate the radioactive aerosol, and a lead (Pb) protective container to hold the radioactive solution during the inhalation procedure. It typically consists of one or several one-way valves to direct the flow of aerosol to the patient, transport tubing to carry the aerosol to the patient, a mouthpiece, and a bacteria filter to trap any exhaled aerosol. This is a single-use device.	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
No Device Sizes

Device Record Status

Public Device Record Key: 0b870044-69b5-422b-9311-90ca004b46ea
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 09, 2017