FDA.reportPublic FDA data

MEDALink

Primary DI
G096MNKS2SNEO0
Brand
MEDALink
Company
Rising Eagle Medical LLC
Model
M-NK-S2S-NEO
Catalog number
M-NK-S2S-NEO
Device description
Nihon Kohden Compatible Disposable SpO2 Sensor, Neonatal/ Adult, 50pcs/box
Published
2023-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172981000Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.2018-06-08DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G096MNKS2SNEO5PackageHIBCC50In Commercial Distribution
G096MNKS2SNEO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse Co-oximeter probe, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
080145608
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
G096MNKS2NORAC30MEDALinkM-NK-S2NOR-AC-3M-NK-S2NOR-AC-32025-10-08
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

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Primary DI, Brand, Company table
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