CANNULA 8MM TEFLON STERILE - 1/packaging 3910141.008

GUDID B154R39101410080

CANNULA 8MM TEFLON STERILE - 1/packaging

WATERS MEDICAL SYSTEMS, LLC

Kidney donor-organ preservation/transport perfusion set
Primary Device IDB154R39101410080
NIH Device Record Key40f81a80-c0de-4e40-9ab1-79b772b85b0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCANNULA 8MM TEFLON STERILE - 1/packaging
Version Model NumberCANNULA 8MM TEFLON STERILE
Catalog Number3910141.008
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB154R39101410080 [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 Date2019-03-20
Device Publish Date2017-02-12

Devices Manufactured by WATERS MEDICAL SYSTEMS, LLC

B15431800030050 - RM3 Filter2019-03-21 RM3 Accessory - Filter
B154O00067900000 - Oxicom 3000 Oximeter2019-03-21 Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this
B154O00072900000 - Oxicom 2100 Oximeter2019-03-21 Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this
B154O00103910003 - CUVETTES DC-80 Box 100 cuvettes & 100 plugs2019-03-21 Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter.
B154O0010391CUVEACH00 - CUVETTES DC-80 Box 100 cuvettes2019-03-21 Disposable cuvettes for use with the Oxicom oximeter.
B154O00340910000 - CONTROL LIQUID, OXICOM, BOX2019-03-21 Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three l
B154O0034091HIG00 - CONTROL LIQUID, OXICOM - High vial2019-03-21 Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three l
B154O0034091LOW00 - CONTROL LIQUID, OXICOM - Low vial2019-03-21 Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three l

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