FDA.reportPublic FDA data

MED-LINK

Primary DI
06944414049986
Brand
MED-LINK
Company
Shenzhen Med-Link Electronics Tech Co.,Ltd.
Model
S0136J-L
Published
2022-12-20
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
K113727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113727000SHENZHEN MED-LINK PULSE OXIMETER PROBEShenzhen Med-Link Electronics Tech Co., Ltd.2013-03-21DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944414049986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944414049986069444140499866944414049986

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA 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. The is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527221129
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944414005289Med-linkVA008BBA2017-03-29
06944414010405Med-linkS0044D-S2017-03-30
06944414031462Med-linkS0044D-S2017-03-30
06944414037945Med-linkED023-3AI2017-03-30
06944414006910MED-LINKW0001BW0001B2022-12-20
06944414007108MED-LINKW0001G2022-12-19
06944414007115MED-LINKW0001FW0001F2022-12-20
06944414008242MED-LINKS0010NE-L2022-12-20
06944414011747MED-LINKS0044D-S2022-12-20
06944414021227MED-LINKS0044D-S2022-12-20
06944414037778MED-LINKS0044D-S2022-12-20
06944414044639MED-LINKW0001C2022-12-21
06944414049962MED-LINKW0001C2022-12-20
06944414049979MED-LINKS0044D-S2022-12-20
06944414049993MED-LINKS0136J-L2022-12-20
06944414050005MED-LINKW0001B2022-12-20
06944414050029MED-LINKS0136J-L2022-12-20
06944414050050MED-LINKS0136J-L2022-12-21
06944414050067MED-LINKS0136J-L2022-12-21
06944414050074MED-LINKS0136J-L2022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572085APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
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