DEVICE: Oxygen Accessory (00848530106034)
Device Identifier (DI) Information
Oxygen Accessory
RP034
In Commercial Distribution
SUNSET HEALTHCARE SOLUTIONS, INC.
RP034
In Commercial Distribution
SUNSET HEALTHCARE SOLUTIONS, INC.
Everflo Pressure Regulator Adapter with Hose
Compatible with all EverFlo Models
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
66777 | Non-fixed medical gas distribution line 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) distribution line to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). 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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
309be946-a922-4f24-8614-a0a452062a21
June 11, 2025
1
June 03, 2025
June 11, 2025
1
June 03, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10848530106031
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8775786738
customerservice@sunsethcs.com
customerservice@sunsethcs.com