Duns Number:080456871
Device Description: AirLife™ Manual Resuscitator Adult Manual Resuscitator Oxygen Reservoir Bag, Adult Mask, P AirLife™ Manual Resuscitator Adult Manual Resuscitator Oxygen Reservoir Bag, Adult Mask, Pressure Manometer
Catalog Number
2K8004M
Brand Name
AirLife™
Version/Model Number
2K8004M
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
OEV
Product Code Name
Cardiopulmonary resuscitation aid kit
Public Device Record Key
c2870b16-fc52-4f12-ab38-7dc5ea35ee70
Public Version Date
February 12, 2020
Public Version Number
1
DI Record Publish Date
February 04, 2020
Package DI Number
50190752114140
Quantity per Package
6
Contains DI Package
10190752114142
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 |