AccessGUDID - DEVICE: MR AIR_PI_DS _

GUDID

Device Identifier (DI) Information

Brand Name: MR AIR_PI_DS _ _ G
Version or Model: 0724109US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GCE, s.r.o.

Primary DI Number: 08592346893443
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 819753190 *Terms of Use

Device Description: The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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?
43438	Non-fixed medical gas cylinder regulator	A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAN	Regulator, Pressure, Gas Cylinder

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 628925a5-9362-4f0d-9f3d-7a062156caf4
Public Version Date: December 20, 2023
Public Version Number: 1
DI Record Publish Date: December 12, 2023