Duns Number:830432451
Device Description: AirLife™ Pediatric Manual Resuscitator 40 (1.0 m) Oxygen Reservoir Tubing, Masks (Tod AirLife™ Pediatric Manual Resuscitator 40 (1.0 m) Oxygen Reservoir Tubing, Masks (Toddler, Child, Adult)
Catalog Number
2K8008BR
Brand Name
AirLife
Version/Model Number
2K8008BR
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
69e86854-c0e1-4e44-8ad4-c6e5f9e1c629
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 26, 2016
Package DI Number
50885403286931
Quantity per Package
10
Contains DI Package
10885403286933
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 |