FDA.reportPublic FDA data

Cables and Sensors

Primary DI
09551028900069
Brand
Cables and Sensors
Company
XINMED SDN. BHD.
Model
S403-01P0
Device description
Reusable SpO2 sensor/Nellcor-OXIMAX/Finger clip/Adult/1.1M/103X
Published
2026-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19551028900066PackageGS110In Commercial Distribution
09551028900069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955102890006619551028900066
09551028900069095510289000699551028900069

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.

Regulatory Flags#

DUNS number
447945496
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09551028900014Cables and SensorsLQ5-90DP02025-09-25
19551028900011Cables and SensorsLQ5-90DP02025-09-25
09551028900007SAGEL01-05-DP2025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320691MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
08052990320707MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
G096MNKS2NORAC30MEDALinkRising Eagle Medical LLCDQA2025-10-08
08052990321704MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-02-27
08052990320264MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990320271MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990322084MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990322213MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
10197344042647MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042678MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042692MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042715MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042739MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
07630002800754HAMILTON-T1Hamilton Medical AGDQA2024-08-21
10843997003343LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003381LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003398LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003404LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003411LNCSMASIMO CORPORATIONDQA2024-08-16
10843997010983RD SETMASIMO CORPORATIONDQA2024-08-16
10843997010990RD SETMASIMO CORPORATIONDQA2024-08-16
07640121880988103149 Calibration GasSenTec AGDQA2024-07-05
07640121880995103164 tCOM+SenTec AGDQA2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGDQA2024-07-05