Duns Number:080728314
Device Description: PRO-FLOW MULTIPURPOSE NASAL CANNULA, M-F 0.35x 0.35, Single
Catalog Number
1097346
Brand Name
Pro-Flow
Version/Model Number
PRO-FLOW NASAL CANNULA, M-F 0.35 x 0.35, Single
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
OLV
Product Code Name
Standard polysomnograph with electroencephalograph
Public Device Record Key
45600775-042e-4478-afd2-135797d4cd4b
Public Version Date
February 26, 2021
Public Version Number
5
DI Record Publish Date
October 05, 2016
Package DI Number
40606959032352
Quantity per Package
10
Contains DI Package
00606959032354
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 |