Duns Number:076769355
Device Description: A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.
Catalog Number
2181
Brand Name
Hobbs Aspiration Catheter
Version/Model Number
2181
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K844550,K844550
Product Code
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
2ea89a71-faeb-4cc6-84d2-d4909d42d4af
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 12, 2017
Package DI Number
M84921811
Quantity per Package
5
Contains DI Package
M84921810
Package Discontinue Date
-
Package Status
-
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |