FDA.reportPublic FDA data

Fingertip Pulse Oximeter

Primary DI
06932562310324
Brand
Fingertip Pulse Oximeter
Company
Guangdong Biolight Meditech Co., Ltd.
Model
M50L
Published
2019-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OCHOximeter, Infrared, Sporting, Aviation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCHOximeter, Infrared, Sporting, AviationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932562310324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932562310324069325623103246932562310324

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530120146
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932562310355Fingertip Pluse OximeterM70D2024-03-29
06932562310362handheld monitorM8002024-03-29
06932562310263Fetal monitorF302018-04-09
06932562310270Fetal monitorF502018-04-09
06932562310287Fetal monitorF802018-04-09
06932562310294Fetal monitorF902018-04-09
06932562310317 Fingertip Pulse OximeterM502019-08-28
06932562310348Fingertip Pulse OximeterM50A2021-06-28
06932562310331patient monitorM90002020-08-10
06932562310300Vital Signs MonitorV92019-07-03
06932562310003Fingertip Pluse OximterM702016-09-07
06932562310010Fingertip Pluse OximeterM70A2016-09-20
06932562310027Fingertip Pluse OximeterM70C2016-09-13
06932562310058Handheld Pulse MonitorM8002016-09-22
06932562310065Handheld Pulse OximeterM7002016-09-22
06932562310089Patient MonitorQ52016-09-22
06932562310096Patient MonitorQ52016-09-22
06932562310102Patient MonitorM85002016-09-22
06932562310119Patient MonitorM95002016-09-22
06932562310126Patient MonitorV62016-09-22

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06938395500314AccuMedShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-27
06938395500284AccuMedShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-15
08719481723408iProvènSevenground Trading B.V.OCH2026-03-09
06973912940525 simplicare IMDKOCH2025-12-03
06951740540377THERMOBIOShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-10-18
00846841092527ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-09-29
06951740540360NOVAShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-08-07
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00846841092701mibestBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00846841092947ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
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00851697006543InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
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00856964007964ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
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06941900601314Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27