Duns Number:022721133
Device Description: Small pediatric oral/nasal pressure monitoring and gas sampling cannula
Catalog Number
5055-7
Brand Name
N/A
Version/Model Number
5055-7
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
K051313,K051313
Product Code
MNR
Product Code Name
VENTILATORY EFFORT RECORDER
Public Device Record Key
ee987686-7560-41e6-a4b5-9a95f127b04a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 10, 2016
Package DI Number
10607411920124
Quantity per Package
25
Contains DI Package
00607411920127
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 |