FDA.reportPublic FDA data

MEDALink

Primary DI
G096MNKS2NORAC30
Brand
MEDALink
Company
Rising Eagle Medical LLC
Model
M-NK-S2NOR-AC-3
Catalog number
M-NK-S2NOR-AC-3
Device description
Adult Reusable SPO2 Finger Clip Sensor - Compatible with Nihon Kohden/Nellcor, 3-Foot Cable
Published
2025-10-08
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
K082846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082846000APK SPO2 PULSE OXIMETER SENSORAPK Technology Co., Ltd.2009-04-03DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G096MNKS2NORAC30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse Co-oximeter probe, reusableA photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a reusable device.

Regulatory Flags#

DUNS number
080145608
Device count
1
Lot or batch
true
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
G0960R867530909LineR-8675309R-86753092024-01-30
G096MNK3NT100MEDALinkM-NK-3NT-10M-NK-3NT-102025-10-08
G096MNKS2NKT100MEDALinkM-NK-S2NKT-10M-NK-S2NKT-102025-10-08
G096MNKS2NOT100MEDALinkM-NK-S2NOT-10M-NK-S2NOT-102025-10-08
G096MPHS2E0840MEDALinkM-PH-S2E-084M-PH-S2E-0842025-10-08
G096MPHS2T0420MEDALinkM-PH-S2T-042M-PH-S2T-0422025-10-08
G096MPHS2T0840MEDALinkM-PH-S2T-084M-PH-S2T-0842025-10-08
G096MPHS2T1200MEDALinkM-PH-S2T-120M-PH-S2T-1202025-10-08
G096MMR5PS0500MEDALinkM-MR-5PS-050M-MR-5PS-0502024-07-27
G096PS3SS05009LinePS-3SS-050PS-3SS-0502024-09-17
G096MDR5TMP100MEDALinkM-DR-5TMP-10M-DR-5TMP-102024-09-15
G096MGEPH10T150MEDALinkM-GE-PH510T-15M-GE-PH510T-152024-07-29
G096MA0816C030030MEDALinkM-A0816-C03-003M-A0816-C03-0032023-03-22
G096MA0816C030040MEDALinkM-A0816-C03-004M-A0816-C03-0042023-03-22
G096MA5085EK2PH0010MEDALinkM-A5085-EK2PH-001M-A5085-EK2PH-0012023-03-22
G096MGE5GEE100MEDALinkM-GE-5GE-E-10M-GE-5GE-E-102025-02-18
G096MGE5GEE150MEDALinkM-GE-5GE-E-15M-GE-5GE-E-152025-02-18
G096MMX40120MEDALinkM-MX40-12M-MX40-122023-04-22
G0963PS03009Line3PS-0303PS-0302022-02-21
G0965SS03009Line5SS-0305SS-0302022-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06924054300623BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-06-04
06931973410890CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
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
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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