Duns Number:022721133
Device Description: Pediatric Oral/Nasal Pressure Monitoring Cannula with 7’ (2.1 m) tube with filter.
Catalog Number
5023-7
Brand Name
N/A
Version/Model Number
5023-7
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
cc024596-145f-4948-9389-8b1cfbfe4310
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10607411500111
Quantity per Package
25
Contains DI Package
00607411500114
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 |