Duns Number:005080650
Device Description: The Non-Metallic Pneumos consist of two plastic end pieces connected by a rubber convolute The Non-Metallic Pneumos consist of two plastic end pieces connected by a rubber convoluted tube. The pieces are also connected internally by a rubber band. A connecting tube of various lengths is attached to the pneumograph assembly. These tube lengths can be 7, 10, 12, or 14 feet or 89 inches depending on customer specifications. The entire assembly is non-metallic so that that it can be used safely in an MRI environment. The Pneumograph is used as respiration sensor. The convoluted tube is attached around the upper or lower torso of the patient and is held in place with a Velcro strap. As the patient breathes, the tube expands and contracts which varies the pressure inside the tube in direct correlation to the breathing pattern. When attached to a pressure sensor, the breathing pattern of the patient can be sensed and recorded. The pneumograph is used as a gating sensor for MRI machines to sense the patient’s breathing pattern. The image acquisition of the MRI is triggered at the bottom of the patient’s breathing cycle when there is minimal movement of the chest cavity.
Catalog Number
76513NM18G
Brand Name
Pneumograph - Non-Metallic 18' w/Connector
Version/Model Number
76513NM18G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IXO
Product Code Name
Synchronizer, Ecg / Respirator, Radiographic
Public Device Record Key
8bc8898b-28ef-40d0-81b5-e4fb78696019
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 21 |