Duns Number:078758082
Device Description: VOCSN Removable Battery Quick Charger
Catalog Number
PRT-01003-000
Brand Name
VOCSN Removable Battery Quick Charger
Version/Model Number
PRT-01003-000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162877
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
251289b6-a14b-44a4-922c-ff7575ccd9fd
Public Version Date
September 06, 2018
Public Version Number
1
DI Record Publish Date
August 06, 2018
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 |