FDA.reportPublic FDA data

Caremed

Primary DI
06970758500159
Brand
Caremed
Company
Shenzhen Caremed Medical Technology Co., Ltd.
Model
C403-01
Device description
Caremed Reusable SpO2 Sensors
Published
2018-02-03
Public version status
Update
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
K153184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153184000Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.2017-01-04DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970758500159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970758500159069707585001596970758500159

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
544335718
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970758507707CaremedSA11Y-49SA11Y-492019-11-01
06970758507691CaremedSA30Y-15RSA30Y-15R2019-10-30
06970758500029CaremedReusable2017-12-08
06970758500166CaremedC403S-152018-02-03
06970758500173CaremedN543-012018-02-03
06970758507608CaremedPWC10-LB-APWC10-LB-A2019-11-01
06970758507622CaremedEHP3R-90P-AEHP3R-90P-A2019-11-01
06970758507639CaremedEHP5R-90P-AEHP5R-90P-A2019-11-01
06970758507646CaremedEHPU385-AEHPU385-A2019-11-01
06970758507677CaremedEHPU585-AEHPU585-A2019-10-31
06970758507615Caremed AD-BA-10AD-BA-102019-10-30
06970758500012Caremedcable2017-12-08
06970758500098CaremedMQB5-90S2018-02-06
06970758500104Caremed2585P2018-02-06
06970758500111CaremedMQ-25862018-02-06
06970758500128CaremedE10R-SH1-N2018-02-06
06970758500135CaremedE10R-MQ2018-02-06
06970758500142CaremedMQ10-LN2018-02-06
06970758507721CaremedTZDHP-PHTZDHP-PH2019-11-01
06970758507806CaremedN2S11-10N2S11-102019-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM 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
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B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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