Duns Number:022721133
Device Description: Adult Oral/Nasal Pressure Monitoring & Gas Sampling Cannula with 7' (2.1 m) tubes with mal Adult Oral/Nasal Pressure Monitoring & Gas Sampling Cannula with 7' (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring.
Catalog Number
M041622-0
Brand Name
N/A
Version/Model Number
M041622-0
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"
Yes
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
K151874,K151874
Product Code
MNR
Product Code Name
VENTILATORY EFFORT RECORDER
Public Device Record Key
2c744860-c026-4a33-9801-54d943a99125
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
December 16, 2016
Package DI Number
10607411889001
Quantity per Package
25
Contains DI Package
00607411889004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |