FDA.reportPublic FDA data

Solairs

Primary DI
06900234100054
Brand
Solairs
Company
Solaris Medical Technology, Inc.
Model
S200A-300101
Device description
BCI Compatible Adult SpO2 Finger Sensor (3.0m cable)
Published
2017-06-16
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061931000SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101Solaris Medical Technology, Inc.2007-01-31DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16900234100051PackageGS120In Commercial Distribution
26900234100058PackageGS132In Commercial Distribution
36900234100055PackageGS140In Commercial Distribution
46900234100052PackageGS160In Commercial Distribution
56900234100059PackageGS180In Commercial Distribution
06900234100054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1690023410005116900234100051
2690023410005826900234100058
3690023410005536900234100055
4690023410005246900234100052
5690023410005956900234100059
06900234100054069002341000546900234100054

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

Sterilization Methods#

Method table
Method

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
06900234100023NoneS100A-090103-62016-11-10
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
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
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09