Duns Number:074574384
Device Description: Intended to provide continuous ventilation to patients requiring respiratory support. The Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for neonate/infant patients.The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.
Catalog Number
-
Brand Name
Neumovent
Version/Model Number
GraphNet Neo
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"
-
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
K111595
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
4227880e-244d-4274-9ed4-1786fb69c195
Public Version Date
January 26, 2022
Public Version Number
4
DI Record Publish Date
October 29, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |