Duns Number:002348191
Device Description: 780-35 CIRCUIT W/ COLUMN
Catalog Number
780-35KIT
Brand Name
HUDSON RCI
Version/Model Number
IPN913824
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OGG
Product Code Name
Humidifier nebulizer kit
Public Device Record Key
f3eae84d-edbf-4595-a105-63711e1805a1
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
August 05, 2019
Package DI Number
24026704660272
Quantity per Package
10
Contains DI Package
14026704660275
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 |