FDA.reportPublic FDA data

OptoMonitor 3

Primary DI
07540184012220
Brand
OptoMonitor 3
Company
Opsens Inc
Model
Pressure output cable - Nihon Kohden 15 pins
Catalog number
F201222
Published
2026-05-04
Public version status
New
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
K202943000
K213854000
K241418000
K251367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
07540184012220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540184012220075401840122207540184012220

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.

Contacts#

Phone, Email table
PhoneEmail
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
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
07540184013012OptoMonitor 3AO cable - Philips/WITT 2.9mF2013012024-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07460691952775TRUWAVEEdwards Lifesciences LLCDXO2026-03-20
07460691955882TRUWAVEEdwards 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
07460691956094TRUWAVE (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
00690103216806TruWaveEdwards Lifesciences LLCDXO2022-08-18
10888277655379MedlineMEDLINE INDUSTRIES, INC.DXO2020-12-25
07460691952829TRUWAVE X 3 (3 CC)Edwards Lifesciences LLCDXO2020-11-12
07460691949270TRUWAVE, VAMPEdwards Lifesciences LLCDXO2020-11-10
00690103199406TRUWAVE, VAMP JR.Edwards Lifesciences LLCDXO2020-08-26
00690103210453Combo KitsEdwards Lifesciences LLCDXO2020-05-12
00690103197129TRUWAVE, VAMP PLUSEdwards Lifesciences LLCDXO2020-04-24