Duns Number:094651270
Device Description: Intrauterine Pressure Monitoring Kit with Amnio Port / Lumen, Dual-Lumen Fluid-Filled Cath Intrauterine Pressure Monitoring Kit with Amnio Port / Lumen, Dual-Lumen Fluid-Filled Catheter / Transducer, 78" Lumen, with 20cc Syringe
Catalog Number
IUP-075
Brand Name
N/A
Version/Model Number
N/A
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
K862873,K862873
Product Code
KXO
Product Code Name
Monitor, Pressure, Intrauterine
Public Device Record Key
afeb250a-651d-429a-b95b-84c80ac5d840
Public Version Date
December 18, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
H671IUP0751
Quantity per Package
10
Contains DI Package
H671IUP0750
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |