RM3 Accessory - Adapter 3200091.005

GUDID B154R32000910050

RM3 Accessory - Filter Adapter

WATERS MEDICAL SYSTEMS, LLC

Kidney donor-organ preservation/transport perfusion set
Primary Device IDB154R32000910050
NIH Device Record Key04b4b3ee-e77e-4a9e-92fc-78a6c5c930ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameRM3 Accessory - Adapter
Version Model NumberRM3 Filter Adapter
Catalog Number3200091.005
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-507-288-7777
Emailinfo@wtrs.com
Phone1-507-288-7777
Emailinfo@wtrs.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB154R32000910050 [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

Devices Manufactured by WATERS MEDICAL SYSTEMS, LLC

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