FDA.reportPublic FDA data

OptoMonitor

Primary DI
07540184020058
Brand
OptoMonitor
Company
Opsens Inc
Model
OpM-mounting pole (2 feet/610mm)
Catalog number
F202005
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
07540184020058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540184020058075401840200587540184020058

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor mountA dedicated mount onto which a visual display unit (VDU), e.g., a patient monitor, can be placed and secured so that it is safely mounted in a position suitable for viewing. This device will provide for adequate vertical and horizontal adjustment possibilities and will be manufactured for hospital use. In some situations a television set may be mounted instead. It will typically be affixed to a wall, ceiling, or the top of, or into, a medical device or system.

Contacts#

Phone, Email table
PhoneEmail
418-781-0333info-medical@opsens.com

Regulatory Flags#

DUNS number
253717946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540184010127OptoMonitorOU Clamp adapter plateF2010122026-09-30
07540184020027OptoMonitorDU Bed‐Rail ClampF2020022026-09-30
07540184020034OptoMOnitorIV Pole C‐ClampF2020032026-09-30
07540184020041OptoMonitorDU Clamp adapter plateF2020042026-09-30
07540184020065OptoMonitorOpM-mounting pole (1 foot/305mm)F2020062026-09-30
07540184020072OptoMonitorOpM-bedrail post clampF2020072026-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540184010127OptoMonitorOpsens IncDXO2026-09-30
07540184010127OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDXO2026-09-30
07540184020034OptoMOnitorOpsens IncDQX2026-09-30
07540184020034OptoMOnitorOpsens IncDXO2026-09-30
07540184020041OptoMonitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDXO2026-09-30
07540184020065OptoMonitorOpsens IncDQX2026-09-30
07540184020065OptoMonitorOpsens IncDXO2026-09-30
07540184020072OptoMonitorOpsens IncDXO2026-09-30
07540184020072OptoMonitorOpsens IncDQX2026-09-30
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
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00885403543459TruWaveBecton, Dickinson And CompanyDXO2026-09-18
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00885403543480TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
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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