Duns Number:080456871
Device Description: AirLife™ Manual Resuscitator Infant Manual Resuscitator 40 Inch (1.0 m) Oxygen Reservoir T AirLife™ Manual Resuscitator Infant Manual Resuscitator 40 Inch (1.0 m) Oxygen Reservoir Tubing, Infant Mask, Pressure Limiting Valve with Lock
Catalog Number
2K8010
Brand Name
AirLife™
Version/Model Number
2K8010
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
OFP
Product Code Name
Anesthesia breathing circuit kit (adult & pediatric)
Public Device Record Key
b2d5b632-2413-43b0-baef-e007dd37275a
Public Version Date
February 12, 2020
Public Version Number
1
DI Record Publish Date
February 04, 2020
Package DI Number
50190752114256
Quantity per Package
6
Contains DI Package
10190752114258
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 |