FDA.reportPublic FDA data

oximeter - RO2

Primary DI
00382098017062
Brand
oximeter - RO2
Company
Raya Pharmaceuticals LLC
Model
1
Device description
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use withthe finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusionscenarios.
Published
2024-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191430000Pulse OximeterShenzhen Yimi Life-Technology Co., Ltd.2019-10-18DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382098017062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382098017062003820980170623820980170620382098017062

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106631637
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974289400223polymer patient examination glove - RayaNitMedium2024-10-31
06974289400353polymer patient examination glove - RayaNitLarge2024-10-31
06974289400360polymer patient examination glove - RayaNitSmall2024-10-31
00382098010506Derma-R Cream12024-10-29

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Primary DI, Brand, Company table
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10884521855403NellcorCovidien LPDQA2026-05-29
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B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03