Home GUDID B631SPPDA1M1 SureLead
Primary DI B631SPPDA1M1
Brand SureLead
Company Authentic Medical
Model SPPDA1M
Published 2024-11-05
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Single use true Product Codes# Code, Name table Code Name DQA Oximeter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQA Oximeter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B631SPPDA1M1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Pulse Co-oximeter probe, single-use A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a single-use device.
Regulatory Flags# DUNS number 078861998 Device count 1 Premarket exempt true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04048675785910 Masimo SpO2 Module for Vista 300/S Shanghai Draeger Medical Instrument Co.,Ltd. DQA 2026-07-13 00010939962218 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 00093351041099 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 00845717013550 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 00845717013567 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 06972040113849 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 06972040113856 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 06931973400563 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973400730 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973400785 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410326 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410333 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410340 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410364 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410371 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410388 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410395 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410401 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410418 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410425 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410432 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410449 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410456 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410647 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410678 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410685 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410692 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410715 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410722 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410739 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09