AccessGUDID - DEVICE: NA (G298153911380050)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 1539113800-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15391138005
Company Name: Control Devices, LLC

Primary DI Number: G298153911380050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119290896 *Terms of Use

Device Description: CGA 870 EMS Oxygen Regulator, 50 psig, Barbed Outlet, Nickel-plated brass Body, 0-15 L/min, 1 DISS 1240 Auxiliary Port

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:	No
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?
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: e1f74dcd-dd29-4bcb-8a55-db2e4d2ca555
Public Version Date: August 02, 2024
Public Version Number: 1
DI Record Publish Date: July 25, 2024