FDA.reportPublic FDA data

OptoMonitor 3

Primary DI
07540184012053
Brand
OptoMonitor 3
Company
Opsens Inc
Model
Pressure output cable - GE CLAB II plus
Catalog number
F201205
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
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142598000
K202943000
K213854000
K241418000
K251367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142598000Opto Wire and OptoMonitor SystemOpsens, Inc.2015-06-12DQX
K202943000OptoMonitor 3Opsens, Inc.2020-11-24DXO
K213854000SavvyWireOpsens, Inc.2022-09-14DQX
K241418000OptoMonitor 3Opsens, Inc.2025-02-12DXO
K251367000OptoMonitor 3Opsens, Inc.2026-01-16DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540184012053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540184012053075401840120537540184012053

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
00885403533665TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543282TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543299TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543305TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543312TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543428TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543435TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543459TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543466TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543473TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543480TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544128TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544135TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544142TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544159TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544166TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544180TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544432TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544470TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544487TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544494TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544500TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544524TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544531TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544555TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544562TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544579TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544586TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403524038TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403524502TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05