Duns Number:314101143
Device Description: The M2786A in combination with the spirometry module M1014A is designed to allow measureme The M2786A in combination with the spirometry module M1014A is designed to allow measurement of airway pressures, flow, minute volume, tidal volume, airway compliance, airway resistance and CO2.
Catalog Number
989803144671
Brand Name
NA
Version/Model Number
Flow Sensor Neonatal
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZC
Product Code Name
Calculator, Pulmonary Function Data
Public Device Record Key
f3c6efd0-9159-412f-bfb2-bf5d76021614
Public Version Date
September 16, 2022
Public Version Number
8
DI Record Publish Date
January 20, 2017
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |