Duns Number:083016063
Device Description: Pediatric. Demand Nasal Cannula, for use with dual port demand valve.
Catalog Number
4827-7-7
Brand Name
N/A
Version/Model Number
4827-7-7
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
K151506,K151506,K151506
Product Code
NFB
Product Code Name
Conserver, oxygen
Public Device Record Key
f716e625-d2e3-417f-97d2-69f464f67406
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10607411400688
Quantity per Package
10
Contains DI Package
00607411400681
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 |