AccessGUDID - DEVICE: Xenon Master Administration Set (00857863007420)

GUDID

Device Identifier (DI) Information

Brand Name: Xenon Master Administration Set
Version or Model: MN0308
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medi/Nuclear Corporation, Inc.

Primary DI Number: 00857863007420
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079628327 *Terms of Use

Device Description: Face Mask, Air-Cushioned, Adult size 5, w/Injection Port & Bacteria Filter

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?
43987	Gas sampling line filter, single-use	A screening device intended to be installed in a reusable gas sampling line or gas measuring instrument to remove and retain bacterial pathogens, and sometimes moisture, from the gas. It is designed to prevent a measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, bedside respiration monitor] and the system it is connected to (e.g., a breathing circuit) from becoming contaminated to reduce the risk of patient cross-contamination. Some types function as a water trap to help minimize damage to the measuring instrument from gas condensation. 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 [?]
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: c88024e4-34bb-4ccb-9c20-a4372943ad7e
Public Version Date: May 07, 2019
Public Version Number: 3
DI Record Publish Date: June 09, 2017