Duns Number:078758082
Device Description: VOCSN Patient Breathing Package (Adult, Active, Oxygen, Blue)
Catalog Number
PRT-00794-00X
Brand Name
VOCSN Patient Breathing Package
Version/Model Number
Adult, Active, Oxygen, Blue
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
Yes
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,K162877
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
ed600a0c-0333-42af-8110-0235c26836fb
Public Version Date
May 13, 2021
Public Version Number
2
DI Record Publish Date
October 07, 2020
Package DI Number
00850018761055
Quantity per Package
10
Contains DI Package
00850018761048
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 |