Duns Number:080456871
Device Description: AirLife™ Adult "Y" Connector with Elbow Thermometer and Pressure Sensing Ports with Caps
Catalog Number
001831
Brand Name
AirLife™
Version/Model Number
001831
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
BWF
Product Code Name
SPIROMETER, THERAPEUTIC (INCENTIVE)
Public Device Record Key
c144cb73-fabb-4de8-bb69-7cdeff130219
Public Version Date
October 21, 2020
Public Version Number
2
DI Record Publish Date
January 17, 2020
Package DI Number
50190752144772
Quantity per Package
50
Contains DI Package
10190752144774
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 |