Duns Number:544423370
Device Description: Invasive BP Adapter CableGE Marquette Compatible, use with Utah transducer, Pressure Tran Invasive BP Adapter CableGE Marquette Compatible, use with Utah transducer, Pressure Transducer, 4.0m
Catalog Number
-
Brand Name
Invasive BP Adapter Cable
Version/Model Number
IBP-MQ-UT40
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182327
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
3f6d1ac8-fe59-49d3-81f0-86a7c1a874d8
Public Version Date
September 06, 2022
Public Version Number
2
DI Record Publish Date
December 25, 2020
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 | 158 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |