FDA.reportPublic FDA data

Cofoe

Primary DI
06950715500262
Brand
Cofoe
Company
Cofoe Medical Technology Co.,Ltd
Model
OXH78
Device description
Pulse Oximeter
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230277000Pulse Oximeter(Model OHT60,OXH78)Cofoe Medical Technology Co., Ltd.2024-01-04DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950715500262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950715500262069507155002626950715500262

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544425204
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950715563090CofoeZBC242026-02-24
06950715500002COFOEZA-012022-01-10
06950715500019COFOEDM3792022-01-10
06950715500026COFOECC3302022-01-10
06950715500033COFOERC3302022-01-10
06950715500040COFOESPTT3302022-01-10
06950715500057COFOEPTT3302022-01-10
06950715500064COFOESPTT9202022-01-10
06950715500071COFOEPTT9202022-01-10
06950715500088COFOECC9202022-01-10
06950715500095COFOEICS920-B2022-01-10
06950715500101COFOEF3002022-01-10
06950715500118COFOEICS300-B2022-01-10
06950715500125COFOECC102022-01-10
06950715500132COFOECN9202022-01-10
06950715500149COFOEICS3302022-01-10
06950715501665CofoeKF-GDD-F012024-07-04
06950715501672CofoeKF-GDD-F022024-07-04
06950715501689CofoeKF-GDD-F032024-07-04
06950715501696CofoeKF-GDD-F042024-07-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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