Duns Number:830432451
Device Description: Infant Manual Resuscitator; Oxygen Resevoir bag, PEEP Valve, Neonatal Mask, Pressure Limit Infant Manual Resuscitator; Oxygen Resevoir bag, PEEP Valve, Neonatal Mask, Pressure Limiting Valve with lock, Pressure Manometer, 14' O2 tubing
Catalog Number
2K7201
Brand Name
AirLife
Version/Model Number
2K7201
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
e5f8c838-a1dc-4d4f-bca9-28ca80ebbed9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 29, 2016
Package DI Number
50885403220775
Quantity per Package
12
Contains DI Package
10885403220777
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 |