Duns Number:053146767
Device Description: A device with a handle used to plug the end of an anesthesia circuit/breathing circuit at 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.
Catalog Number
AM 100P
Brand Name
AM 100P Anesthesia Flush Plug
Version/Model Number
AM 100P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
2fe7f954-d884-47d6-9ba7-8ecc14ec069d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 27, 2017
Package DI Number
M996AM100P5
Quantity per Package
50
Contains DI Package
M996AM100P0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |