FDA.reportPublic FDA data

None

Primary DI
06900234100023
Brand
None
Company
Solaris Medical Technology, Inc.
Model
S100A-090103-6
Device description
Reusable Adult SpO2 Sensor for Use with Commander III device.
Published
2016-11-10
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
66900234100025PackageGS1125In Commercial Distribution
06900234100023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6690023410002566900234100025
06900234100023069002341000236900234100023

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
527945351
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06900234100085SolarisT200A-0901012016-11-24
06900234100092SolarisS100A-0901102016-12-30
06900234100115SolarisT100A-1600872016-09-23
06900234100221SolarisT100A-3000872016-09-23
06900234100245Avante/PacificNSPH30202020-01-20
06900234100177SolairsT100A-0901102020-01-10
06900234100191SolarisT100A-0900872020-01-10
06900234100207SolarisT100P-0900872020-01-09
06900234100047SolairsS200A-0901012017-06-16
06900234100054SolairsS200A-3001012017-06-16
06900234100108SolairsT100A-3001102017-06-16
66900234100025NoneS100A-090103-62016-11-10
56900234100080SolarisT200A-0901012016-11-24
56900234100097SolarisS100A-0901102016-12-30
56900234150115SolarisT100A-1600872016-09-23
56900234150221SolarisT100A-3000872016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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