Duns Number:002348191
Device Description: SOFTECH BI-FLO Cannula w/ Gas Sampling Line (Male Luer Connector)
Catalog Number
1844
Brand Name
HUDSON RCI
Version/Model Number
IPN042841
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
K961150,K961150
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
bf28ec24-6763-49e9-8768-0e7321263cb0
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
24026704580334
Quantity per Package
25
Contains DI Package
04026704580330
Package Discontinue Date
March 12, 2018
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |