Duns Number:080456871
Device Description: Adult Filtered Bypass Heat and Moisture Exchanger (BHME)
Catalog Number
003021
Brand Name
AirLife™
Version/Model Number
003021
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
BYD
Product Code Name
CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
Public Device Record Key
96580e01-4654-44a1-9721-5fb49b849fa9
Public Version Date
September 13, 2022
Public Version Number
1
DI Record Publish Date
September 05, 2022
Package DI Number
50190752105926
Quantity per Package
25
Contains DI Package
10190752105928
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |