Duns Number:078758082
Device Description: V+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or
Catalog Number
PRT-01185-001
Brand Name
VOCSN
Version/Model Number
V+Pro, 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
Product Code
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
8197dba0-2e9a-4b28-b5d3-391089bbceb8
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
April 30, 2021
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. | 43 |