FDA.reportPublic FDA data

Orantech

Primary DI
06941691974482
Brand
Orantech
Company
Orantech Inc.
Model
SS-174-PS30
Device description
Kernel Medical Compatible, Pediatric Soft Tip, 3.0M
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
06941691974482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941691974482069416919744826941691974482

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
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
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
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549919APKAPK Technology Co.,Ltd.DQA2026-03-17
06946725513606APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513613APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513620APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513637APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513644APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513651APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513668APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513675APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513682APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513699APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513705APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513712APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513729APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513736APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513743APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513750APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513767APKAPK Technology Co.,Ltd.DQA2026-03-10