Duns Number:603864294
Device Description: The TEEClean automated cleaner disinfector is designed to provide enzymatic cleaning and h The TEEClean automated cleaner disinfector is designed to provide enzymatic cleaning and high-level disinfection of Transesophageal (TEE) ultrasound probes. The system uses TEEZyme enzymatic cleaner as well as TD-5 or TD-8 disinfectants, which are designed to be used only with the TEEClean automated cleaner disinfector. The disinfectant bottles cannot be reused in the system.
Catalog Number
-
Brand Name
TEEClean®
Version/Model Number
CS-TCD-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PSW
Product Code Name
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Public Device Record Key
bf72fdf0-43ad-43c5-8ab6-f0dcbb7d88ea
Public Version Date
October 03, 2019
Public Version Number
1
DI Record Publish Date
September 25, 2019
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. | 5 |