Duns Number:002348191
Device Description: Universal Neonatal Ventilator Circuit Single Heated Limb with Remote Temperature Port
Catalog Number
780-02
Brand Name
HUDSON RCI
Version/Model Number
IPN045182
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
K903083,K903083
Product Code
BZO
Product Code Name
SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
Public Device Record Key
283d3ba4-bb06-41e7-9214-fd1a9bb3b4cf
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
September 15, 2018
Package DI Number
24026704597936
Quantity per Package
20
Contains DI Package
04026704597932
Package Discontinue Date
September 30, 2019
Package Status
Not 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 |