Duns Number:830432451
Device Description: Airlife™ Isothermal™ Breathing Circuit Pediatric Respiratory Circuit Heated
Catalog Number
6461-H12
Brand Name
AirLife
Version/Model Number
6461-H12
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
BZE
Product Code Name
HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
Public Device Record Key
1ff30d77-4181-48a3-85aa-9e91748e831c
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
50885403167438
Quantity per Package
20
Contains DI Package
10885403167430
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |