Duns Number:080728314
Device Description: PRO-FLOW NASAL CANNUAL, ADULT 16"
Catalog Number
P1328
Brand Name
Pro-Flow
Version/Model Number
PRO-FLOW NASAL CANNUAL, ADULT 16"
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"
-
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
-
Product Code
MNR
Product Code Name
VENTILATORY EFFORT RECORDER
Public Device Record Key
1e094dd3-13ca-4d70-8ad0-11cbda63fa81
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
September 30, 2016
Package DI Number
30606959032218
Quantity per Package
60
Contains DI Package
00606959032217
Package Discontinue Date
December 31, 1999
Package Status
Not in Commercial Distribution
Package Type
Multipack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 151 |
2 | A medical device with a moderate to high risk that requires special controls. | 3279 |