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
5044-7-7
Brand Name
N/A
Version/Model Number
5044-7-7
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
-
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
BZQ
Product Code Name
Monitor, breathing frequency
Public Device Record Key
4826c8b6-d9a3-4b0f-a118-fa436387297b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10607411500449
Quantity per Package
25
Contains DI Package
00607411500442
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 |