AccessGUDID - DEVICE: DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE (00612649186115)

GUDID

Device Identifier (DI) Information

Brand Name: DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE
Version or Model: 22115W-61
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 22115W-61
Company Name: King Systems Corporation

Primary DI Number: 00612649186115
Issuing Agency: GS1
Commercial Distribution End Date: October 10, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 009299017 *Terms of Use

Device Description: XENON CIRCUIT

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:	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?
40908	Xenon administration system, diagnostic nuclear medicine	An assembly of devices which is considered to be a component of a nuclear medicine (NM) imaging system [e.g., a gamma camera or a single photon emission computed tomography (SPECT)] and is used as a rebreathing device to deliver gas to the patient and contain the exhaled radioactive xenon gas used during real-time imaging studies of lung function, blood flow or other physical or physiological parameters. It is designed to minimize release of radioactive gas into the working environment during imaging procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYT	System, rebreathing, radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953513	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size 1

Device Record Status

Public Device Record Key: 07eb028c-9b15-43f3-9d66-a366d41b24af
Public Version Date: October 11, 2019
Public Version Number: 5
DI Record Publish Date: September 21, 2016