Duns Number:118380146
Device Description: Transpac™ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (PO Transpac™ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT)
Catalog Number
852-011-46104-58
Brand Name
ICU Medical
Version/Model Number
852-011-46104-58
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,K061573
Product Code
DRS
Product Code Name
Transducer, blood-pressure, extravascular
Public Device Record Key
fc27f617-b167-4977-a38d-7f33aae561dd
Public Version Date
October 27, 2021
Public Version Number
1
DI Record Publish Date
October 19, 2021
Package DI Number
10840619097421
Quantity per Package
20
Contains DI Package
00840619097424
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |