Duns Number:078758082
Device Description: V+Pro Emergency, English: The VOCSN Unified Respiratory System is intended to provide cont V+Pro Emergency, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. www.VentecLife.com
Catalog Number
PRT-01201-000
Brand Name
VOCSN
Version/Model Number
V+Pro Emergency, English
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K162877,K162877
Product Code
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
78194d1d-3c9f-4b47-a85f-3acd88dcca44
Public Version Date
April 21, 2020
Public Version Number
1
DI Record Publish Date
April 13, 2020
Package DI Number
00855573007853
Quantity per Package
1
Contains DI Package
00855573007945
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |