FDA.reportPublic FDA data

OptoMonitor 3

Primary DI
07540184020096
Brand
OptoMonitor 3
Company
Opsens Inc
Model
OpM3 OU-DU RS-232 comm cable
Catalog number
F232009
Published
2020-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K193620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193620000OptoMonitor 3Opsens, Inc.2020-06-18DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540184020096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540184020096075401840200967540184020096

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac catheterization laboratory computerA dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-677-3671info@opsens-medical.com

Regulatory Flags#

DUNS number
253717946
Device count
1
DM exempt
true
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
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
00885403524618TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524717TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524779TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524809TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524847TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524946TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525462TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525486TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403527411TruWaveBecton, Dickinson And CompanyDXO2026-05-30
07460691952775TRUWAVEEdwards Lifesciences LLCDXO2026-03-20
00690103210828Combo KitsEdwards Lifesciences LLCDXO2025-07-15
07460691925298TRUWAVE/VAMPEdwards Lifesciences LLCDXO2024-09-05
07460691925731TRUWAVE X 2 (3 CC) /VAMP 98 IN (250 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691926769TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-05
07460691930179TRUWAVE X 2 (3CC) / VAMP JR 54 IN (136 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691948990TRUWAVE X 2 (3 CC) /VAMP 86 IN (220 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691949003TRUWAVE (3 CC) /VAMP 88 IN (225 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691949553TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691924840TRUWAVE X 3 (3 CC) /VAMP 75 IN (190 CM)Edwards Lifesciences LLCDXO2024-09-04
07460691924956TRUWAVE, VAMP JREdwards Lifesciences LLCDXO2024-09-04
07460691947221TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691947245TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691947467TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691949287TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)Edwards Lifesciences LLCDXO2024-09-04
00852004007208Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No GuidewireENDOPHYS HOLDINGS, LLCDXO2024-02-29
00852004007222Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No GuidewireENDOPHYS HOLDINGS, LLCDXO2024-02-29
00852004007031Endophys Pressure Sensing Sheath Kit - 8F 11 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
00852004007062Endophys Pressure Sensing Sheath Kit - 6F 12 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
00852004007079Endophys Pressure Sensing Sheath Kit - 8F 25 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
10888277804128Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXO2023-07-29