DEVICE: NA (G2982108080)

Device Identifier (DI) Information

NA
2108-08
In Commercial Distribution
210808
Control Devices, LLC
G2982108080
HIBCC

1
119290896 *Terms of Use
CGA 540 Oxygen Regulator, 50 psig, DISS 1240 Outlet
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CAN Regulator, Pressure, Gas Cylinder
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f96d6c1a-af5c-4b39-a5cc-b72ba1a52091
August 16, 2024
1
August 08, 2024
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
G2982108083 50 G2982108080 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE