FDA.reportPublic FDA data

OptoMonitor

Primary DI
07540184020010
Brand
OptoMonitor
Company
Opsens Inc
Model
OpM OU-DU communication cable
Catalog number
F202001
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142598000Opto Wire and OptoMonitor SystemOpsens, Inc.2015-06-12DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540184020010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540184020010075401840200107540184020010

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
418-781-0333info-medical@opsens.com
800-537-2802CustomerServiceNA@Haemonetics.com

Regulatory Flags#

DUNS number
253717946
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540184012220OptoMonitor 3Pressure output cable - Nihon Kohden 15 pinsF2012222026-05-04
07540184013203OptoMonitor 3Direct AO cable - Edwards transducerF2013202026-05-04
07540184013227OptoMonitor 3Direct AO cable - Utah transducerF2013222026-05-04
07540184320462OptoMonitor 3Capture Unit KitF2320462026-05-04
07540184030019SavvyWireX-SmallF30012023-04-13
07540184030026SavvyWireSmallF30022023-04-13
07540184011131OptoMonitor 3AUX interface cable - GE TRAM D15 S4 WBF2011132024-12-05
07540184011148OptoMonitor 3AUX interface cable - GE X5F2011142024-12-05
07540184011155OptoMonitor 3AUX interface cable - Siemens VibeF2011152024-12-05
07540184011162OptoMonitor 3AUX interface cable - Schwarzer CardisF2011162024-12-05
07540184011179OptoMonitor 3AUX interface cable - Fysicon QMAPPF2011172024-12-05
07540184011186OptoMonitor 3AUX interface cable - Siemens Vibe AO2F2011182024-12-05
07540184012060OptoMonitor 3Pressure output cable - Nihon KodenF2012062024-12-05
07540184012077OptoMonitor 3Pressure output cable - Fukuda Denshi FCF2012072024-12-05
07540184012145OptoMonitor 3Pressure output cable - Ortivus CoroNetF2012142024-12-05
07540184012152OptoMonitor 3Pressure output cable - Claris WorkMateF2012152024-12-05
07540184012169OptoMonitor 3Pressure output cable - Schwarzer CardisF2012162024-12-05
07540184012183OptoMonitor 3Pressure output cable - Fysicon QMAPPF2012182024-12-05
07540184012190OptoMonitor 3Pressure output cable - Siemens SensisF2012192024-12-05
07540184012206OptoMonitor 3Pressure output cable - METEK DavidF2012202024-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07
06947358524021Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06947358535454Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
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00816349015083CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349012570Safari2Lake Region MedicalDQX2026-06-25
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00816349012594Safari2Lake Region MedicalDQX2026-06-25
00816349013676WallStentLake Region MedicalDQX2026-06-25
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
00885403524618TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524717TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524779TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30