DEVICE: AM 100P Anesthesia Flush Plug (M996AM100P0)
Device Identifier (DI) Information
AM 100P Anesthesia Flush Plug
AM 100P
In Commercial Distribution
AM 100P
INSTRUMENTATION INDUSTRIES, INCORPORATED
AM 100P
In Commercial Distribution
AM 100P
INSTRUMENTATION INDUSTRIES, INCORPORATED
A device with a handle used to plug the end of an anesthesia circuit/breathing circuit at two possible locations: the Y-piece or the gas sampling elbow. The temporary plugging of the anesthesia breathing circuit allows anesthetic gases to be flushed from the anesthesia machine through the WAG (waste anesthetic gas) scavenging line by way of continuous oxygen/air flow rate over a set amount of time, or by activating the flush valve and applying positive bag pressure in repeated succession. This practice reduces the amount of anesthetic gas released into the operating room and thus reduces harmful gas exposure to operating room personnel and premature anesthetic gas exposure to patients during preoxygenation or mask induction.
There is no patient contact as the plug must be removed before the breathing circuit can be attached to a mask, endo/naso-tracheal tube, or any other breathing device.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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61621 | Breathing circuit pressure detection port plug |
A non-sterile device designed to seal the port of a breathing circuit pressure detection adaptor/connector (e.g., Y-piece) when the port is not needed for pressure monitoring. It is typically a small Luer cap made of plastic (e.g., polysulphone). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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
2fe7f954-d884-47d6-9ba7-8ecc14ec069d
March 29, 2018
2
July 27, 2017
March 29, 2018
2
July 27, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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M996AM100P5 | 50 | M996AM100P0 | In Commercial Distribution | Ziplock Bag | |
M996AM100P4 | 25 | M996AM100P0 | In Commercial Distribution | Ziplock Bag |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
412-854-1133
raqa@iiimedical.com
raqa@iiimedical.com