Duns Number:022721133
Device Description: Demand Nasal Cannula (adult)with 4' (1.2 m) O2 supply tube, for use with Dual Port Demand Demand Nasal Cannula (adult)with 4' (1.2 m) O2 supply tube, for use with Dual Port Demand Valve.
Catalog Number
M838152-0
Brand Name
N/A
Version/Model Number
M838152-0
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
Yes
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
Product Code
NFB
Product Code Name
Conserver, oxygen
Public Device Record Key
22b0c0ce-34a3-4262-a6f3-dd6e7db695e4
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
December 16, 2016
Package DI Number
10607411301473
Quantity per Package
25
Contains DI Package
00607411301476
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 |