FDA.reportPublic FDA data

Orantech

Primary DI
06941691962519
Brand
Orantech
Company
Orantech Inc.
Model
SS-009RB-MY36
Device description
Masimo Compatible, Multi-Site Y, 3.6M
Published
2025-11-21
Public version status
New
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
K181270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181270000Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.2018-09-07DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941691962519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941691962519069416919625196941691962519

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
544423370
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970706360668ETCO2 SensorCTM-RP012020-12-25
06941691934233Orantech ET-3005R-PH-A2026-01-29
06941691934240Orantech ET-3005R-PH-I2026-01-29
06941691938279Orantech EL-PH3-90G-A2026-01-29
06941691948865Orantech EL-PH3-90G-I2026-01-29
06941691983132Orantech IBP-KR-MD0172026-01-29
06941691905431Orantech IBP-PH-2MIR402026-01-16
06941691982906Orantech IBP-GE-MD0172026-01-16
06941691982913Orantech IBP-SL-MD0172026-01-16
06941691982920Orantech IBP-NKB-MD0172026-01-16
06941691982937Orantech IBP-NKC-MD0172026-01-16
06941691982944Orantech IBP-DGB-MD0172026-01-16
06941691982951Orantech IBP-DGC-MD0172026-01-16
06941691982968Orantech IBP-DGD-MD0172026-01-16
06941691982975Orantech IBP-DGE-MD0172026-01-16
06941691982982Orantech IBP-MRB-MD0172026-01-16
06941691982999Orantech IBP-CR-MD0172026-01-16
06941691983002Orantech IBP-BLT-MD0172026-01-16
06941691983019Orantech IBP-KTN-MD0172026-01-16
06941691983026Orantech IBP-CL-MD0172026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725516188APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516195APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516201APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516218APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516225APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516232APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516249APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516256APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516263APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516270APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516287APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516300APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516317APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516324APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516331APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516348APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516355APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516362APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516379APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516386APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516393APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516409APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516416APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516423APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516430APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516447APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516454APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516461APKAPK Technology Co.,Ltd.DQA2026-03-11