Duns Number:093608594
Device Description: LoFlo CO2 Sampling O2 Delivery Cannula w/Dehumidification Tubing INFANT/NEONATAL NASAL
Catalog Number
1149476
Brand Name
Respironics
Version/Model Number
1149476
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
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
-
Product Code
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
e2f4d1b4-82ae-43b7-ab5d-7e18ee16b8f3
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
June 09, 2021
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 | 66 |
2 | A medical device with a moderate to high risk that requires special controls. | 61 |