Duns Number:080456871
Device Description: AirLife™ Tri-Flo™ Suction Catheter With Control Port
Catalog Number
T261C
Brand Name
AirLife™
Version/Model Number
T261C
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
-
Product Code
BSY
Product Code Name
CATHETERS, SUCTION, TRACHEOBRONCHIAL
Public Device Record Key
fff6b897-4321-4f16-afc0-6e564a9109fc
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
February 03, 2020
Package DI Number
50190752145519
Quantity per Package
100
Contains DI Package
10190752145511
Package Discontinue Date
-
Package Status
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |