FDA.reportPublic FDA data

Oxicom 2100 Box Kit

Primary DI
B154OXIKIT21003
Brand
Oxicom 2100 Box Kit
Company
WATERS MEDICAL SYSTEMS, LLC
Model
Oxicom 2100 Kit
Catalog number
0007290.000
Device description
Oxicom 2100 Box containing 100ct cuvette/plugs & QC 1,2,3 sticks
Published
2017-02-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921519000OXICOM-2100Waters Instruments, Inc.1992-10-23DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B154OXIKIT21003PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac oximeterA mains electricity (AC-powered) photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation. It is typically used in conjunction with a fibreoptic oximeter catheter (e.g., a Swan-Ganz catheter) that is introduced via a vein in the groin or neck to measure mixed venous oxygen saturation (SvO2) or evaluate intracardiac shunts.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
556957871
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
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
B154W39300050150WCM Training Cassette - Non SterileWCM3930005.0152018-04-04
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