WCM Cassette (included in WCM cassettes kit) - 1/s 3930005.014

GUDID B154W39300050110

The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygena

WATERS MEDICAL SYSTEMS, LLC

Kidney donor-organ preservation/transport perfusion set
Primary Device IDB154W39300050110
NIH Device Record Key02db59ad-011f-4d97-81f9-f2a98c422480
Commercial Distribution StatusIn Commercial Distribution
Brand NameWCM Cassette (included in WCM cassettes kit) - 1/s
Version Model NumberWCM Cassette
Catalog Number3930005.014
Company DUNS556957871
Company NameWATERS MEDICAL SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB154W39300050110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2017-02-12

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