MEDIPINES CORPORATION

Address:22815 Savi Ranch Pkwy Ste E,Yorba Linda,CA,92887,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (3) Analyzer, Gas, Oxygen, Gaseous-Phase (CCL) (3) Computer, Oxygen-Uptake (BZL) (3) Oximeter (DQA) (1)

Premarket Exempt

Clear

MediPines Gas Exchange Monitor - 00860001261509 Catalog Number : AGM100

Device Description : The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter resp The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.

Device Class : 2

Duns Number: 058309398

Premarket Exempt : No

Product Code : DQA, CCL, BZL, CCK

Prescription Use : Yes

Device Count : 1

MediPines Single Patient Use Breathing Circuit - 00860001261516 Catalog Number : AGM316-10, AGM316-50, AGM316-100

Device Description : Breathing Circuit Kit, Single Patient Use, 10

Device Class :

Duns Number: 058309398

Premarket Exempt : No

Product Code : CCL, CCK, BZL

Prescription Use : Yes

Device Count : 10

MediPines Gas Exchange Monitor Starter Kit - 00860001261530 Catalog Number : MPSK10

Device Description : Breathing Circuit and Nose Clip, Single Use, 10 pieces each

Device Class :

Duns Number: 058309398

Premarket Exempt : No

Product Code : BZL, CCK, CCL

Prescription Use : Yes

Device Count : 10

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