Duns Number:002348191
Device Description: Reusable Corrugated Tubing 60 in. Length
Catalog Number
18660
Brand Name
HUDSON RCI
Version/Model Number
IPN049814
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
-
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
BZO
Product Code Name
SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
Public Device Record Key
d34e1311-3b0f-4933-b365-e6e78ce0677a
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
May 09, 2019
Package DI Number
24026704661200
Quantity per Package
2
Contains DI Package
14026704661203
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 |