Duns Number:002348191
Device Description: ConchaSmart Column
Catalog Number
382-10
Brand Name
HUDSON RCI
Version/Model Number
IPN913861
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTT
Product Code Name
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Public Device Record Key
d634883a-328c-4e89-9c34-30554e75538e
Public Version Date
January 18, 2021
Public Version Number
3
DI Record Publish Date
August 05, 2019
Package DI Number
24026704660678
Quantity per Package
10
Contains DI Package
14026704660671
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |