Duns Number:078758082
Device Description: VOCSN Humidifier Bypass (Blue)Available as - 10-pack (00855573007372) - 4-Pack of Humidi VOCSN Humidifier Bypass (Blue)Available as - 10-pack (00855573007372) - 4-Pack of Humidifier Bypass (00855573007136) with 4-pack of Adult, Active, Heated, Blue Circuit (00855573007921)
Catalog Number
PRT-00832-001
Brand Name
VOCSN Humidifier Bypass
Version/Model Number
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,K162877
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
efb6c921-d490-4778-9b1a-ec6e34629c6c
Public Version Date
November 16, 2020
Public Version Number
7
DI Record Publish Date
November 11, 2017
Package DI Number
00855573007372
Quantity per Package
10
Contains DI Package
00855573007136
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 |