Duns Number:080935429
Device Description: Intrauterine Pressure Catheter,Transducer Tipped, Dual Lumen
Catalog Number
56300
Brand Name
Kendall
Version/Model Number
56300
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
-
Product Code
KXO
Product Code Name
MONITOR, PRESSURE, INTRAUTERINE
Public Device Record Key
78328dd6-7993-41dc-967d-ee888f743511
Public Version Date
October 26, 2020
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20884527004901
Quantity per Package
10
Contains DI Package
30884527004908
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |