Duns Number:002348191
Device Description: AQUA+F, HCH Bacterial /Viral Filter with Swivel
Catalog Number
1577
Brand Name
HUDSON RCI
Version/Model Number
IPN042610
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"
Yes
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
K961914,K961914
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
e5b8d7a2-3a44-432b-ab33-0f51ab96359c
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
44026704399114
Quantity per Package
20
Contains DI Package
04026704399116
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 |