WAVES CONTROL UNIT 3900042.000

GUDID B154W39000420000

The WAVES “single kidney” machine perfusion device is a three-part system composed of a control unit, a disposable “WCM” cassette, and remote monitori

WATERS MEDICAL SYSTEMS, LLC

Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set
Primary Device IDB154W39000420000
NIH Device Record Keycad15d98-f40b-46d8-8373-11b76ee65029
Commercial Distribution StatusIn Commercial Distribution
Brand NameWAVES CONTROL UNIT
Version Model NumberWAVES CONTROL UNIT
Catalog Number3900042.000
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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
Phone507-288-7777
Emailinfo@wtrs.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB154W39000420000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-20
Device Publish Date2017-02-12

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