Duns Number:556957871
Device Description: DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre- DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (refer to diagram), designed for use on the Waters WAVES control unit. HOW SUPPLIED: The Waters WCM cassette is wrapped in a sterile wrap, sealed in a polyethylene bag, and is provided STERILE (ethylene oxide) fluid pathway. The Waters WCM cassette is intended for single-use only. CONTENTS: One (1) STERILE Waters WCM disposable cassette. One (1) STERILE Drape.Five (5) STERILE Specimen Tubes
Catalog Number
3930005.014
Brand Name
WCM Kit
Version/Model Number
WCM Kit
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111521,K111521
Product Code
KDN
Product Code Name
System, Perfusion, Kidney
Public Device Record Key
cfc8b079-0c8f-4e9c-9f00-1f47d5fc6b25
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
February 12, 2017
Package DI Number
3930005014
Quantity per Package
6
Contains DI Package
B154W39300050123
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |