WCM Training Cassette - Non Sterile

Primary DI
B154W39300050150
Brand
WCM Training Cassette - Non Sterile
Company
WATERS MEDICAL SYSTEMS, LLC
Model
WCM
Catalog number
3930005.015
Device description
WCM Training Cassette - Non Sterile
Published
2018-04-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDNSystem, Perfusion, Kidney

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDNSystem, Perfusion, KidneyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111521000WAVESWaters Medical Systems, LLC2012-02-16KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B154W39300050150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Kidney donor-organ preservation/transport perfusion setA collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
507-288-7777info@wtrs.com

Regulatory Flags#

DUNS number
556957871
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B154W39300050020WAVES/WCM Sterile DrapeDRAPE STERILE PACK - 1drape/bag (included in WCM c3910140.0012017-02-12
B154W39300050123WCM KitWCM Kit3930005.0142017-02-12
B154R39000400040RM3 RENAL PERFUSION MONITORRM33900040.0042017-01-23
B154W39201400226WAVES Specimen TubeWAVES Specimen Tube3930005.0142017-02-12
B154W39300050110WCM Cassette (included in WCM cassettes kit) - 1/sterile bagWCM Cassette3930005.0142017-02-12
B154O00067900000Oxicom 3000 OximeterOxicom 30000006790.0002017-02-12
B154O00072900000Oxicom 2100 OximeterOxicom 21000007290.0002017-02-12
B154OXIKIT21003Oxicom 2100 Box KitOxicom 2100 Kit0007290.0002017-02-12
B154OXIKIT30003Oxicom 3000 Box KitOxicom 3000 Kit0006790.0002017-02-12
B154R39100010043RM3 Tool KitRM3 Tool Kit3910001.0042017-03-27
B154W39000420000WAVES CONTROL UNITWAVES CONTROL UNIT3900042.0002017-02-12
BI54W39301400070WAVES Transport BagWAVES Transport Bag3930140.0072017-02-12
B15431800030050RM3 FilterRM3 Filter3180003.0052017-02-12
B154O00103910003CUVETTES DC-80 Box 100 cuvettes & 100 plugsCuvette/Plug Kit0010391.0002017-02-12
B154O0010391CUVEACH00CUVETTES DC-80 Box 100 cuvettesCUVETTE DC-800010391.0002017-02-12
B154O00340910000CONTROL LIQUID, OXICOM, BOXCONTROL LIQUID, OXICOM, BOX0034091.0002017-02-12
B154O0034091HIG00CONTROL LIQUID, OXICOM - High vialCONTROL LIQUID, OXICOM - High vial0034091.0002017-02-12
B154O0034091LOW00CONTROL LIQUID, OXICOM - Low vialCONTROL LIQUID, OXICOM - Low vial0034091.0002017-02-12
B154O0034091MED00CONTROL LIQUID, OXICOM - Medium vialCONTROL LIQUID, OXICOM - Medium vial0034091.0002017-02-12
B154O0034791PLGEA00CUVETTES DC-80 Box 100 cuvettes - PlugsDC-80 Cuvette Plugs0010391.0002017-02-12

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