Duns Number:118380146
Device Description: Transpac™ IV 15' Cable for use with Disposable Transducer
Catalog Number
011-42661-64
Brand Name
ICU Medical
Version/Model Number
011-42661-64
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
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
K061573
Product Code
DRS
Product Code Name
Transducer, blood-pressure, extravascular
Public Device Record Key
d965ff20-706d-4e0a-bc70-0137859d57ad
Public Version Date
September 03, 2021
Public Version Number
1
DI Record Publish Date
August 26, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4887 |