FDA.reportPublic FDA data

Medke

Primary DI
06971018118060
Brand
Medke
Company
Shenzhen MedKe Technology Co., Ltd
Model
P9318E
Published
2023-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152390000Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.2016-08-18DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971018118060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971018118060069710181180606971018118060

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
529655709
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971018113195MedkeT43062026-04-27
06971018118411MedkeT13062026-04-27
06971018118558MedkeT23062026-04-27
06971018118725MedkeT61062026-04-27
06971018118947MedkeT51062026-04-27
06971018119012MedkeT33062026-04-27
06971018110613MedkeP1019-012023-10-19
00192243000098MedkeP1315F-01BC2023-10-24
00192243000104Medke P1319D-012023-10-24
06971018111030MedkeP9119A2023-10-19
06971018117698MedkeP1719-012023-10-19
06971018118046MedkeP8119A2023-10-19
06971018115236MedkeP1119-012019-12-11
06971018115243MedkeP1219-012019-12-11
06971018115250MedkeP1319-012019-12-11
06971018115267MedkeP1419-012019-12-11
06971018115298MedkeP1719-012019-12-11
06971018115366MedkeP11419-012019-12-11
06971018115274MedkeP1519-012019-12-11
06971018115281MedkeP1619-012019-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09