Duns Number:076769355
Device Description: A non-sterile device designed to monitor the pressure of a balloon catheter being inflated A non-sterile device designed to monitor the pressure of a balloon catheter being inflated by injecting and aspirating fluid or air within the balloon during a medical procedure. It typically is used in conjunction with a syringe/plunger, a locking mechanism, and a connecting tube for monitoring pressure within the balloon [e.g., in atmosphere(s) (atm) or pounds per square inch (psi)]. This is a single-use device.
Catalog Number
4630
Brand Name
Hobbs Inflation Monitor
Version/Model Number
4630
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
K921026
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
3745d660-3030-4a41-82a7-96e66a53c573
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |