FDA.reportPublic FDA data

Microlife

Primary DI
00642632950249
Brand
Microlife
Company
MICROLIFE USA, INC.
Model
OXY550 BT
Device description
The Fingertip Pulse Oximeter is a non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate.
Published
2022-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10642632950246PackageGS1100In Commercial Distribution
00642632950249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1064263295024610642632950246
00642632950249006426329502496426329502490642632950249

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.

Regulatory Flags#

DUNS number
176387785
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719003406516MicrolifeFR1MZ1-B2026-01-31
14719003406513MicrolifeFR1MZ1-B2026-01-31
00642632472000MicrolifeNEB2002020-05-13
00642632900251microlifeBPHJE2-D2025-03-21
10642632900258microlifeBPHJE2-D2025-03-21
04719003315085MicrolifeCRO-BP3MX1-3C12025-03-11
06970388169511MicrolifeCuff-L-WBPA2025-02-10
16970388169518MicrolifeCuff-L-WBPA2025-02-10
04719003315030MicrolifeBP3SZ1-1WatchBP O3 2G2024-11-27
04719003315047MicrolifeBP3SZ1-1CENWatchBP O3 2G2024-11-27
14719003315037MicrolifeBP3SZ1-1WatchBP O3 2G2024-11-27
14719003315044MicrolifeBP3SZ1-1CENWatchBP O3 2G2024-11-27
04719003631284MicrolifeBP3SZ1-1AFIB2024-10-28
06970388169160MicrolifeBP3MX1-32024-10-28
06970388169221MicrolifeCuff-LXL-WBPH2024-10-28
06970388169429MicrolifeCuff-L-WBPH2024-10-28
06970388169528MicrolifeCuff-LXL-WBPA2024-10-28
14719003631281MicrolifeBP3SZ1-1AFIB2024-10-28
16970388169167MicrolifeBP3MX1-32024-10-28
16970388169228MicrolifeCuff-LXL-WBPH2024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
07290016714265SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-09-08
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18