Duns Number:022721133
Device Description: Infant nasal cannula headset sub assembly. Disposable, single patient use.Obsolete--subass Infant nasal cannula headset sub assembly. Disposable, single patient use.Obsolete--subassembly items no longer sold. Marketing SKU reduction. Not a medical device.
Catalog Number
PF03471
Brand Name
N/A
Version/Model Number
PF03471
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 06, 2020
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
K151421
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
a91247cb-2120-4d94-acd7-2f2542def0d8
Public Version Date
March 22, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |