Duns Number:730624095
Device Description: The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborn The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
Catalog Number
LGH-84604001
Brand Name
NeoNatalie Resuscitator (US)
Version/Model Number
LGH-84604001
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
K132172,K132172
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
a456c50d-2795-45b9-80d8-151e151c4356
Public Version Date
September 29, 2020
Public Version Number
2
DI Record Publish Date
April 22, 2019
Package DI Number
07045432092042
Quantity per Package
12
Contains DI Package
07045432092035
Package Discontinue Date
September 28, 2020
Package Status
Not 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 80 |