Duns Number:078758082
Device Description: The VOCSN Carry Bag supports everyday mobility with an included shoulder strap and attachm The VOCSN Carry Bag supports everyday mobility with an included shoulder strap and attachment points for securing VOCSN to a wheelchair, bed rail, and other mounts. The Carry Bag is compatible with the VOCSN Roll Stand, the Travel Suction Canister, and other accessories. It also allows access to both removable, rechargeable batteries during use.
Catalog Number
PRT-01143-000
Brand Name
VOCSN Carry Bag
Version/Model Number
Carry Bag
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)
-
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
f705c51c-8e0e-43ca-a537-45c1a97b74c1
Public Version Date
November 04, 2019
Public Version Number
1
DI Record Publish Date
October 25, 2019
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 |