FDA.reportPublic FDA data

INTEGRAL PROCESS Cables & Leadwires

Primary DI
03700506303151
Brand
INTEGRAL PROCESS Cables & Leadwires
Company
NISSHA MEDICAL TECHNOLOGIES SAS
Model
SPO2 Cable
Catalog number
90797CIP
Device description
SP02 EXTENSION CABLE MINDRAY COMPATIBLE
Published
2022-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162768000ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cablesIntegral Process Sas2017-08-16DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700506303151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700506303151037005063031513700506303151

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
391906658
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700506318940INTEGRAL PROCESS Cables & Leadwires72473-US2022-12-22
03700506319480INTEGRAL PROCESS Cables & Leadwires70612GEJ5T-US2022-12-22
03700506304653INTEGRAL PROCESS Cables & Leadwires72191-US2024-02-23
03700506319046INTEGRAL PROCESS Cables & Leadwires72191-US-3.50M2024-02-23
03700506319466INTEGRAL PROCESS Cables & Leadwires70612SJ5T-US2024-01-19
03700506320189INTEGRAL PROCESS Cables & Leadwires71041-US-5.5M2023-04-19
03700506320196INTEGRAL PROCESS Cables & Leadwires72350-US-5.5M2023-04-19
03700506303601INTEGRAL PROCESS Cables & Leadwires70611NGJ3-US2023-02-23
03700506303625INTEGRAL PROCESS Cables & Leadwires70611NGJ5-US2023-02-23
03700506303700INTEGRAL PROCESS Cables & Leadwires70612NGJ5-US2023-02-23
03700506303809INTEGRAL PROCESS Cables & Leadwires70618NGJ3-US2023-02-23
03700506304349INTEGRAL PROCESS Cables & Leadwires71780-US2023-02-23
03700506304790INTEGRAL PROCESS Cables & Leadwires72465-US2023-02-23
03700506304813INTEGRAL PROCESS Cables & Leadwires72466-US2023-02-23
03700506311422INTEGRAL PROCESS Cables & Leadwires72465S-US2023-02-23
03700506312924INTEGRAL PROCESS Cables & Leadwires70610NGJ5-US2023-02-23
03700506318902INTEGRAL PROCESS Cables & Leadwires72712-US2023-02-23
03700506318919INTEGRAL PROCESS Cables & Leadwires72711-US2023-02-23
03700506319176INTEGRAL PROCESS Cables & Leadwires71780S-US2023-02-23
03700506319459INTEGRAL PROCESS Cables & Leadwires70612SJ5-US2023-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19
08719689142537QMAPPFysicon B.V.DSA2026-05-19
08719689142544QMAPPFysicon B.V.DSA2026-05-19
08719689142551QMAPPFysicon B.V.DSA2026-05-19
08719689142568QMAPPFysicon B.V.DSA2026-05-19
08719689142575QMAPPFysicon B.V.DSA2026-05-19
08719689142582QMAPPFysicon B.V.DSA2026-05-19
08719689142599QMAPP Fysicon B.V.DSA2026-05-19