FDA.reportPublic FDA data

Solaris

Primary DI
56900234150115
Brand
Solaris
Company
Solaris Medical Technology, Inc.
Model
T100A-160087
Device description
Philips Compatible Adult SpO2 Soft-Finger Sensor (1.6m cable)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100077000NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103Solaris Medical Technology, Inc.2010-10-07DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16900234110111PackageGS120In Commercial Distribution
26900234120117PackageGS132In Commercial Distribution
36900234130113PackageGS140In Commercial Distribution
46900234140119PackageGS160In Commercial Distribution
56900234150115PackageGS180In Commercial Distribution
66900234160111PackageGS1100In Commercial Distribution
66900234160227PackageGS1100In Commercial Distribution
06900234100115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1690023411011116900234110111
2690023412011726900234120117
3690023413011336900234130113
4690023414011946900234140119
5690023415011556900234150115
6690023416011166900234160111
6690023416022766900234160227
06900234100115069002341001156900234100115

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06900234100054SolairsS200A-3001012017-06-16
06900234100108SolairsT100A-3001102017-06-16
66900234100025NoneS100A-090103-62016-11-10
56900234100080SolarisT200A-0901012016-11-24
56900234100097SolarisS100A-0901102016-12-30
56900234150221SolarisT100A-3000872016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410746CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410753CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410760CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410777CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410784CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410791CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410807CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09