Duns Number:080456871
Device Description: Pediatric Manual Resuscitator 40” (1.0 m) Oxygen Reservoir Tubing, Masks (Toddler, Child, Pediatric Manual Resuscitator 40” (1.0 m) Oxygen Reservoir Tubing, Masks (Toddler, Child, Adult), Pressure Limiting Valve with Lock
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
-
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
f3476405-aff6-49b9-b505-a77dc0db0cbf
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 2021
Package DI Number
50190752149739
Quantity per Package
10
Contains DI Package
10190752149731
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 |