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
M996AM100P0
HIBCC

1
053146767 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2fe7f954-d884-47d6-9ba7-8ecc14ec069d
March 29, 2018
2
July 27, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
M996AM100P5 50 M996AM100P0 In Commercial Distribution Ziplock Bag
M996AM100P4 25 M996AM100P0 In Commercial Distribution Ziplock Bag
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
412-854-1133
raqa@iiimedical.com
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