Duns Number:092673953
Device Description: Neonatal/Infant Resuscitator w/Peep and Mask, AMBU Disposable Manometer
Catalog Number
-
Brand Name
BagEasy
Version/Model Number
562111DM
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
K940581,K940581
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
5785f5e7-6729-4bb1-8506-8c809bdd45a4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
20709078562116
Quantity per Package
12
Contains DI Package
00709078562112
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |