FDA.reportPublic FDA data

coreray reusable SpO2 sensor

Primary DI
06928737883526
Brand
coreray reusable SpO2 sensor
Company
Shenzhen Coreray Technology Co., Ltd
Model
CR001-3106A
Published
2018-10-08
Public version status
Update
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
K173368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173368000Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.2018-08-31DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06928737883526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06928737883526069287378835266928737883526

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
544519750
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06928737818146Patient Monitoring Cable (SpO2 Extension Cable)CR002-53012026-05-11
06928737883533coreray ECG cableCR005-73012018-10-09
06928737883540coreray EKG cableCR007-55022018-10-09
06928737883557coreray ECG cableCR005-73022018-10-09
06928737883564coreray ECG cableCR005-04012018-10-09
06928737845791AILECR009-R-PU-0052023-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03