Duns Number:002348191
Device Description: HUMID-VENT 2S with SOFT FLEX Tube, Assembled
Catalog Number
14412-BQY
Brand Name
HUDSON RCI
Version/Model Number
IPN913681
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYD
Product Code Name
CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
Public Device Record Key
337446fd-c425-4404-959d-c83e2e80b22b
Public Version Date
May 22, 2019
Public Version Number
1
DI Record Publish Date
May 14, 2019
Package DI Number
24026704658866
Quantity per Package
100
Contains DI Package
14026704658869
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |