Cannula 5mm SS, Non-Sterile 3910142.005

GUDID B154R39101420050

Cannula 5mm Stainless Steel, Non-Sterile

WATERS MEDICAL SYSTEMS, LLC

Kidney donor-organ preservation/transport perfusion set
Primary Device IDB154R39101420050
NIH Device Record Key2cbba9bc-fb03-4693-9c75-606c9d6a3ca7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannula 5mm SS, Non-Sterile
Version Model Number5mm SS
Catalog Number3910142.005
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 Usefalse
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

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

Device Dimensions

Lumen/Inner Diameter5 Millimeter
Lumen/Inner Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB154R39101420050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B154R39101420050]

Moist Heat or Steam Sterilization


[B154R39101420050]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-20
Device Publish Date2018-05-02

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