Duns Number:022721133
Device Description: Pediatric Nasal Pressure Monitoring Cannula with 7' (2.1 m) tube with male luer connection
Catalog Number
5022-7
Brand Name
N/A
Version/Model Number
5022-7
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
655c4a3c-c9c8-4e33-97f6-2fdc90eed5d3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10607411500104
Quantity per Package
25
Contains DI Package
00607411500107
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 |