Duns Number:830432451
Device Description: AirLife Infant Single Limb Heated Wire Circuit single-limb, single-heat, continuous-flow c AirLife Infant Single Limb Heated Wire Circuit single-limb, single-heat, continuous-flow circuit (>4 L/min)
Catalog Number
AH132
Brand Name
AirLife
Version/Model Number
AH132
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K151959,K151959
Product Code
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
466a6c67-133a-48f6-a475-ef84081261e5
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
May 15, 2017
Package DI Number
50885403276192
Quantity per Package
10
Contains DI Package
10885403276194
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| 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 |