Duns Number:078758082
Device Description: VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue)
Catalog Number
PRT-00802-001
Brand Name
VOCSN Patient Breathing Package
Version/Model Number
Pediatric, 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
5a415d3c-a6ca-4643-9137-070a075266b0
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
July 11, 2018
Package DI Number
00855573007594
Quantity per Package
10
Contains DI Package
00855573007587
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 |