Duns Number:320025190
Device Description: High quality workmanship Ultrasonic Flow Probes for the measurement ofblood flow in vessel High quality workmanship Ultrasonic Flow Probes for the measurement ofblood flow in vessels and grafts. The probes are showing excellent accuracyand stability. Calibration data are stored in the probe.The probes can be manually and automatically cleaned and disinfected andsterilized with steam, ethylene oxide (EtO), low temperature steam and form -aldehyde sterilisation (LTSF) and low temperature plasma (LTP). We supportup to 50 sterilisation cycles
Catalog Number
11344
Brand Name
SonoTT Vascular Probe
Version/Model Number
11344
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2018
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111730
Product Code
DPW
Product Code Name
Flowmeter, Blood, Cardiovascular
Public Device Record Key
f37a23d6-f200-4dfc-8c91-59fc445a54f8
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 20, 2018
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. | 23 |